Image guided catheters and methods of use

ABSTRACT

An interventional medical device is provided that incorporates a forward-directed ultrasound or optical coherence tomography imaging system that is replaceable depending on how close the device is to the target site for a given medical procedure, the device and system integrated into a single minimally invasive device comprising a first probe housing, needle guide assembly and sheath, a sleeve lock for closing a normally open needle channel of a needle guide of the first distal assembly and a second probe and cable housing assembly locked to the first distal probe housing, needle guide assembly and sheath by a locking tab. The probe and cable housing assembly may comprise a linear phased ultrasound array and an accelerometer for orienting an image produced by the device with the gravitational field of the earth. The medical device can be in the form of an image guided catheter or probe, used in a body orifice, externally on skin tissue or subcutaneously. The device comprises a replaceable and reusable ultrasound imaging assembly (and or OCT assembly) and replaceable interventional devices such as a removable introducer needle, hollow biopsy needle, syringe or other medical instrument. The imaging system may comprise one or more small ultrasound or OCT imaging systems that can be replaceably integrated into the device by replacing the reusable second probe and cable housing assembly.

CROSS-REFERENCES

This application is a continuation of U.S. patent application Ser. No.15/845,756, which is a continuation-in-part of U.S. patent applicationSer. No. 14/865,151, filed Sep. 25, 2015, (now U.S. Pat. No. 9,855,021),which is a continuation-in-part of U.S. patent application Ser. No.13/847,902, filed Mar. 20, 2013 (now U.S. Pat. No. 9,149,257), and acontinuation-in-part of U.S. patent application Ser. No. 13/973,476,filed Aug. 22, 2013; U.S. patent application Ser. No. 13/847,902 is acontinuation of U.S. patent application Ser. No. 11/871,282, filed Oct.12, 2007 (now U.S. Pat. No. 8,403,859) and a continuation-in-part ofU.S. patent application Ser. No. 11/782,991 filed Jul. 25, 2007 (nowU.S. Pat. No. 8,403,858), both of which claim the benefit of the rightof priority to U.S. provisional patent application Ser. No. 60/851,451filed Oct. 12, 2006; U.S. patent application Ser. No. 13/973,476 claimsthe benefit of the right of priority to U.S. provisional patentapplication Ser, No. 61/692,443, filed Aug. 23, 2012; and thisapplication claims the benefit of the right of priority to U.S.provisional patent application Ser. No. 62/526,170, filed Jun. 28, 2017;to U.S. provisional patent application Ser. No. 62/527,865, filed Jun.30, 2017; to U.S. provisional patent application Ser. No. 62/527,905,filed Jun. 30, 2017; and to U.S. provisional patent application Ser. No.62/590,464, filed Nov. 24, 2017, the disclosures of all priorityapplications being hereby incorporated by reference into the presentapplication in their entirety.

TECHNICAL FIELD

Embodiments of the illustrated and disclosed aspects and features relateto minimally invasive interventional medical devices having removableand/or reusable components of an ultrasound imaging system andassociated channel for introduction of a removeable needle and tools forperforming the minimally invasive procedures, and, more particularly, toan ultrasound image guided catheter and methods of use, the catheterelongated housing having a dome-shaped, flat or tapered ultrasoundtransducer assembly tip at a distal (patient) end, a removable andreusable ultrasound transducer assembly component and a removable andreplaceable needle, sheath or tool assembly component. The transducersensor assembly slidably enters a probe and needle guide housing bodyand is clasped into a locked position. The ultrasound transducerassembly comprises, for example, a linear phased array at a centerfrequency of approximately fifteen megahertz (range on ten to fortymegahertz) and a pitch between elements of approximately one wavelength(or lambda) (range between 0.85 and 1.15λ or wavelength of centerfrequency. A conventional pitch of one half lambda or a pitch in therange of 0.5 and 0.6λ or wavelength of the center frequency may be used.The ultrasound transducer assembly is preferably replaceable andreusable with optical coherence tomography or with other assemblies withultrasound transducers having higher or lower center frequency ranges.The needle or tool assembly may be inserted vertically into a parallelchannel of a needle guide, the needle/tool assembly being replaceablewith instruments/tools for use at a target site for a medical procedure.The plane of the ultrasound image is mechanically aligned with theneedle guide delivery port to ensure that the needle/syringe/tool isvisible in the image without the physician needing to make anyadjustments to either the imaging array or sheath orientation. In oneembodiment, the tool/instrument channel or channels and imaging channelor channels are mounted side-by-side (the needle guide preferablylocated on top). A patient body region of interest may be visible by theultrasound transducer assembly from external skin tissue, via a bodyorifice or subcutaneously. In an embodiment, the needle/tool guide maybe mounted above the image guided catheter. Moreover, in otherembodiments the needle/tool channel or lumen may extend beyond atransducer window at the distal (patient) end or the transducer windowmay not extend beyond the needle/tool channel/lumen or lumens.

BACKGROUND

Ultrasound operates by creating an image from sound in threesteps—producing a sound wave, receiving echoes, and interpreting thoseechoes to create an image.

Ultrasound has many uses in medical applications. For example,ultrasound is routinely used during pregnancy to provide images of thefetus in the womb. Generally, a water-based gel is applied to thepatient's skin, and a hand-held probe, called an ultrasound transducer,is placed directly on and moved over the patient. The probe typicallycontains one or a plurality of piezoelectric elements that vibrates andgenerates a sound wave when a current is applied. In ultrasound devices,the sound wave is typically produced by creating short, strongvibrational pulses using the piezoelectric transducer element. The soundwave is reflected (echoes) from tissues and structures and returns anecho, which vibrates the transducer elements and turns the vibrationinto electrical pulses. The electrical pulses are then sent to aprocessor and then to an ultrasound scanner having a display where theyare transformed into a viewable analog or digital image on the display.Ultrasound contrast agents (which may be introduced into the blood) areknown for enhancing visibility of blood vessels so that smooth needles,sheaths or tools may avoid inadvertent puncture of a vessel. Surroundinghuman tissue of blood vessels of interest in a particular medicalprocedure or blood flow may be seen in an ultrasound image. Also,methods for improving the surface echogenicity of tools are known whichpermit, for example, improved reflection of sound waves back to theultrasound transducer assembly.

While general-purpose ultrasound machines may be used for most imagingpurposes, certain procedures require specialized apparatus. For example,in a pelvic ultrasound, organs of the pelvic region can be imaged usingeither external or internal ultrasound devices used together or incombination with ultrasound image guided catheters of the presentinvention (implanted or inserted, for example, via the rectal opening,the mouth, a vein or other useable openings to a human body). Incontrast, echocardiography, which is used in cardiac procedures, canrequire specialized machines to take into account the dynamic nature ofthe heart.

Ultrasound has advantages over other imaging methods such as magneticresonance imaging (MRI) and computed tomography (CT) or opticalcoherence tomography (OCT), but these, along with known X-ray imagingcan be used together to gather displayed images of a patient's region ofinterest. Ultrasound produces a sequence of images in real time and so,for example, a mother may see the ultrasound image of her baby and seethe baby's heartbeat. Also, ultrasound is relatively inexpensivecompared to techniques such as MRI and CT. Ultrasound also is capable ofimaging muscle and soft tissue very well, can delineate interfacesbetween solid and fluid filled spaces (for example, for cardiocentesisprocedures with a pericardial sac), and may show the structure of organsand their internal components (such as a heart valve). Ultrasoundrenders live images in real time in sequence and can be used, forexample, to view blood vessels in relation to the operation of organs inreal time (with or without contrast). Ultrasound has no known long-termside effects and generally causes little to no discomfort to a patient.Further, ultrasound equipment is widely available, flexible andportable.

However, ultrasound does have some drawbacks. When used on obesepatients, image quality is compromised as the overlying adipose tissuescatters the sound and the sound waves are required to travel greaterdepths, resulting in signal weakening (attenuation) on transmission andreflection back to the ultrasound transducer (especially asurface-mounted ultrasound system). Even in non-obese patients, depthpenetration is limited, thereby making it difficult to obtain images ofstructures located deep within the body. Further, ultrasound has troublepenetrating bone and, thus, for example, ultrasound imaging of the brainwithin skull bone is limited from external to animal bone. Ultrasoundalso does not perform well when there is gas present (as in thegastrointestinal tract and lungs). Still further, a highly skilled andexperienced ultrasound operator is necessary to obtain quality images.These drawbacks do not, however, limit the usefulness of ultrasound as amedical diagnostic and treatment tool.

The use of ultrasonic apparatus for imaging areas of the human body,either alone or in combination with other instruments, is known, forexample, for guiding therapeutic instruments through a catheter to afield of view within a human body. For example, ultrasound devices havebeen combined with catheters for insertion into a body, usually througha vein or artery, to reach a part of the human body for examination ortreatment. Such devices are commonly known in the art as “imagingcatheters.”

For example, U.S. Pat. No. 5,704,361 to Seward et al. discloses avolumetric image ultrasound transducer underfluid catheter system. Forexample, FIGS. 2-9 and 11-12 of Seward et al. and their attendantdescription suggest specific methods of intervention for imagingpurposes in the vicinity of a human heart. To reach such an area ofinterest within a human body, an ultrasound imaging and hemodynamiccatheter may be advanced via the superior vena cava to a tricuspid valveannulus. A distal end of a cylindrical body includes a guide wire accessport and a guide wire provides a means of assuring that the catheterreaches a target for imaging. A surgical tool may be fed through thecatheter to the area imaged.

U.S. Pat. No. 6,572,551 to Smith et al. provides another example of animaging catheter. Tools such as a suction device, guide wire, or anablation electrode, may be incorporated in an exemplary catheteraccording to Smith et al.

U.S. Pat. No. 5,967,984 to Chu et al. describes an ultrasound imagingcatheter with a cutting element which may be an electrode wire or alaser fiber. FIGS. 1 and 2 of Chu et al. also describe a balloon 14 anda means to inflate the balloon. The balloon, for example, may beutilized to dilate a vessel having strictures imaged via the imagingcatheter.

Other imaging catheters are known. For example, U.S. Pat. No. 6,162,179to Moore teaches bending (using a pull wire) an acoustic window into aknown and repeatable arc for improved three-dimensional imaging. U.S.Pat. No. 6,306,097 to Park et al. discloses an intravascular ultrasoundimaging catheter whereby a first lumen provides access for an ultrasoundimaging catheter and a second lumen provides a working port for a tool.U.S. Pat. No. 5,505,088 to Chandraratna et al. teaches using a 200 MHztransducer in an ultrasonic microscope combined with a catheter as adelivery means for the microscope to provide imaging of myocardialtissue. According to Chandraratna et al., lower frequency ultrasoundtransducers can provide deeper penetration in the tissue but do notprovide the image quality provided by higher frequencies.

Optical coherence tomography (OCT) operates in a similar manner toultrasound in producing an image having high resolution but thetransmitted light signal reaches only so far into human tissue. Whitelight diodes covering the visible spectrum may be used to transmit lightthrough, for example, a transparent window to the human tissue, and theecho is received and passed to a display which may create athree-dimensional image. Near infrared and other radio frequencies,visible and invisible, may be applied to create an image of human tissueat, for example, a site of a medical procedure.

Needle guides are known for probes and catheters. Typically, a needleguide may be located at the top of the probe or catheter and provide achannel having a diameter for a specific needle size. The needle may beinserted subcutaneously with or without imaging by sliding the needlefrom the surgeon end through the needle channel. Also, the needle guideis in one piece and incapable of being opened to release the needle fromthe probe or catheter. The needle is removed by pulling the needlethrough the needle channel toward the surgeon end, and the needle maycapture debris or fluid such as blood at the needle channel tip as theneedle is pulled out of the needle channel.

All the above-cited references are incorporated by reference as to anydescription which may be deemed essential to an understanding ofillustrated and discussed aspects and embodiments of devices and methodsherein and as summarized below.

SUMMARY OF THE EMBODIMENTS

This summary is intended to introduce, in simplified form, a selectionof concepts that are further described in the Detailed Description. Thissummary is not intended to identify key or essential features of theclaimed subject matter, nor is it intended to be used as an aid indetermining the scope of the claimed subject matter.

In an image-guided catheter such as represented by U.S. Pat. No.9,149,257 entitled “Image Guided Catheters and Methods of Use” issuedOct. 6, 2015 (the '257 patent) by the same inventor, per FIG. 3A, anultrasound beam generated by a transducer element 210 of an ultrasoundimaging channel 214 provides a cone-shaped imaging zone 301 which candisplay a needle 208 directed parallel to the ultrasound beam andlocated within a sheath or lumen or plurality of lumens. (The '257patent should be deemed to be incorporated by reference as to its entirecontents). One the other hand, the needle 208, (sheath or tool) beingparallel to the cone-shaped ultrasonic beam, may be difficult to see inthe imaging zone 301 because the needle, sheath or lumen is very thin indiameter, may comprise a smooth surface, and may extend in the samedirection as the ultrasound beam is projected (parallel to the sonicbeam) from the thin, minimally invasive image-guided catheter so thatthe sonic beam will tend to follow the angles of impingement andreflection and are intended to project from the needle, sheath or toolin a direction deeper into, for example, a human body in which the imageguided catheter of FIG. 3A is inserted. Also, it is desirable tovisualize the needle, sheath or tool itself to determine the directionof its movement within the human body from the point of entry of thehuman body to an area of interest such as the human heart, the liver orother organ of interest. In one embodiment, the needle or sheath may behollow (in another, solid) and may be removed once the catheter islocated at a site of interest and replaced in real time with a tool. Inanother embodiment, the tool may be used simultaneously (in its ownlumen) with the needle or sheath to bend or guide the needle or sheathto the region of interest from a patient's skin surface.

The following additional U.S. Patents and published applications of Dr.Theodore Abraham should be deemed to be incorporated by reference as totheir entire subject matter and refer to similar image guided catheters,implanted ultrasound devices, wired or wireless ultrasound devices andthe like which may receive signals from echogenic needles, sheaths ortools and surrounding tissue or blood: U.S. Pat. No. 8,038,622 issuedOct. 18, 2011; U.S. Pat. Nos. 8,147,413 and 8,147,414, issued Apr. 13,2012; U.S. Pat. Nos. 8,403,858 and 8,403,859 issued Mar. 26, 2013, andU.S. 2016/008,1658 published Mar. 24, 2016.

A device in accordance with one or more aspects described herein mayinclude ultrasound imaging using a conventional piezoelectric linear orphased array transducer or a more recently developed photo-acoustictransducer (light transmit, sound receive) providing high resolutionimaging or optical imaging through the use of fiber optics, i.e. usingoptical coherence imaging, through an additional channel or lumen than asingle ultrasound channel and a single needle/instrument channel, or acombination of these, to provide a wide range of imaging capabilitiescoupled with one or more diagnostic, therapeutic, or interventionalcapabilities. In one or more embodiments, according to aspects herein,an interventional ultrasound device preferably may include an expendablehousing (useful for one minimally invasive medical procedure) while theultrasound assembly may be reusable. An optional handle for the use of asurgeon may help the surgeon guide the progress of the device as itsdistal end progresses into a human body subcutaneously or into a bodyorifice (as necessary). The image guided catheter device may have aproximal end (the surgeon end) and a distal end, a first lumen, alsoreferred to as an imaging lumen or channel, for holding a replaceableimaging ultrasound transducer assembly of varying center frequency (forexample between ten and forty megahertz) and a second lumen which mayextend to a distal end or short of the distal end of the expendablehousing, also referred to as a needle/instrument lumen, for, forexample, a needle guide and for replacing a removable needle or sheathwith another interventional device such as a cutting and graspinginstrument, sheath or syringe (referred to generally herein as a tool).The imaging transducer assembly may be adapted to removably fit into theimaging lumen at the distal (patient) end of the housing. The transducerassembly may be removed, reused, and/or replaced with imaging transducerassemblies having ultrasound transducers of higher or lower frequencyranges or OCT assemblies and adapted to be used for different purposesin real time, for example, during a medical procedure or compriseadditional lumen, for example, for optical coherence tomography imagingor with other ultrasound devices which may be surface-mounted orimplanted.

Illustrative aspects described herein include a minimally invasiveinterventional medical device that can provide ultrasound imagingcoupled together with one or more interventional capabilities. Theultrasound frequencies present in a sound wave output by such a devicecan range between twenty kilohertz and several hundred megahertz orultrasound frequencies in the gigahertz range. Frequencies in the lowerrange, for example, below one megahertz, and particularly in the 100-200kilohertz range, can be used, for example, to provide heat therapy or totreat conditions such as blood clots and provide low resolution, longrange imaging. Frequencies above one megahertz can be used to providehigher resolution imaging at shorter range. For example, ultrasoundfrequencies in the 25 to 30 megahertz range can be used to image organssuch as the eye or can be used to provide imaging of small animals.Higher frequencies, for example, ultrasound frequencies in the onehundred to several hundred megahertz range, can be used to provide evenhigher-resolution imaging, sometimes known as high-frequency ultrasoundmicroscopy, at a target site within a body undergoing a medicalprocedure. A feature of the imaging channel of an embodiment of thepresent invention is that the ultrasound transducer may be replaceableduring a medical procedure to provide imaging for any of these purposesduring the procedure via replacement of a replaceable and reusableultrasound transducer and cabling module, for example, with one ofhigher center frequency and greater resolution including opticalcoherence tomography imaging or the use of a plurality of opticalfibers. Center frequencies for ultrasound imaging via a linear phasedarray may vary from ten to forty megahertz and have a sufficiently smalldiameter for subcutaneous or body orifice use (ear canal, nasal cavity,throat or rectum). In embodiments not shown, more than one imaginglumen/channel may be used at a time during a medical procedure ifprovided in an embodiment of an image guided catheter.

An embodiment of a device in accordance with one or more aspects andfeatures described herein can include a reusable, removable ultrasonicimaging device assembly or module having one or more forward-directedultrasound transducers, for example, comprising a linear phased array orcomprise optical fibers or optical coherence tomography that can beinserted into a distal (patient) end of an expendable catheter housingby way of a lengthwise slot in the proximal end of the housing so as toprovide access to the distal end (lumen) of the housing from which, whenthe ultrasonic or other imaging device assembly is moved forward intothe distal end and operated, a direct forward view forming an imagingzone of the tissue being accessed comprising a pie-shaped cross sectionmay be obtained from the ultrasonic or other imaging device assembly anddisplayed on a display. The imaging zone of the ultrasound transducermay be seen through a dome or window (which may be transparent) of aprobe housing assembly having an openable needle guide. An introducerneedle may be used during introduction of the device subcutaneously orthe probe end be simply used external to the human body or in an orificeof the human body followed by its replacement with an interventionaldevice or instrument introduced via a needle guide, for example, to cutand remove unwanted tissue, a biopsy needle to gather a tissue sample, asyringe to remove unwanted liquid or a sheath to permit a repair orreplacement of a heart valve.

An embodiment of a device in accordance with one or more aspects andfeatures described herein may comprise a minimally invasive image guidedcatheter device having a removable, replaceable introducer needle,sheath or instrument (tool) assembly in the needle/instrument lumen andthen the one or more replaceable forward-directed ultrasound transduceror optical assemblies that can be inserted and moved forward into theimaging lumen of the single expendable housing via the lengthwise slotat the proximate end so that the introducer needle, sheath or instrumentand the imaging catheter (expendable) housing along with the replaceabletransducer assembly can be introduced into a body substantiallysimultaneously via one or more proximate channels. The introducerneedle, sheath (or instruments replacing the needle or sheath), thedistal tip of the housing and the path taken by the needle or sheath canbe viewed within the imaging zone of the replaceable transducer assemblyas the entire assembly comprising transducer assembly, housing andinstrument/syringe/needle/sheath/tool assembly components may travelthrough an animal/human body subcutaneously to a target site for amedical procedure or be simply used at skin surface or inserted via abody orifice. A solid or hollow needle, syringe, sheath or other toolmay be replaced in the needle channel with medical instruments orcarriers of replacement body parts such as heart valves when theoperating site via the sheath is reached.

An alternative embodiment of a device (shown in priority patentapplications and issued patents and published applications of theinventor introduced above) in accordance with aspects described hereincan have one or more ultrasonic transducers located along one or moresides of the image guided transducer assembly and housing to obtainperipheral views of the body tissue under medical procedure. Thereplaceable imaging transducer assembly and removable introducer needleor sheath assembly may comprise a forward-directed ultrasound transducerimaging assembly operating within, for example, a first and second,sonic or optical predetermined range of ultrasound/optical frequenciesto enter the human body, then guide the entire image guided catheter tothe target site of a medical procedure and provide high resolution (highfrequency or optical coherence or both) imaging at the target site of amedical procedure. A tool such as a clasper or microelectromechanicalmotor system may be introduced to help guide the sheath or needleupwards or downwards to reach the site of interest or may replace theneedle or sheath when located at the site of interest, for example, torepair or replace a heart valve.

The ultrasound features of the device can serve to guide and facilitatesurgical procedures performed with the image guided catheter device. Forexample, a medical professional such as a surgeon can receive directhigh-resolution vision of a targeted area in real time. The lumen forexample, for receiving a syringe or surgical instrument and introducerneedle assembly may have inserted and locked into place therein, ahollow syringe needle for withdrawing unwanted fluids or tissuespecimens or a tapered solid needle for, for example, skin penetrationand internal body wall puncture may be used when needed via the toolreplacement feature and multiple usage of a single instrument lumen orchannel or used together with a tool in a second parallel lumen andvisioned by ultrasound or OCT or other imaging channel.

A wide variety of other interventional elements also can be incorporatedinto such a device. Examples of replacements for a syringe/needleassembly in the needle or sheath lumen may include a syringe forremoving fluids, an instrument having a biopsy needle for extractingtissue specimens, an instrument including a biopsy blade, an instrumentcarrying a micro-motive electronic manipulator (MEMS) device, aninstrument comprising a clasper for cutting and clasping tissue forremoval and other instruments as described in priority patentapplications and issued patents. A syringe needle may be hollow or solidand may be used as an introducer needle or larger diameter sheath foranother device and for delivering medication or for removing unwantedfluid (for example, unwanted fluid in the pericardial sac or space).

For example, in some embodiments of a device in accordance with one ormore aspects and features described herein, an ultrasound imagingtransducer assembly can be combined with an interventional catheterhaving an introducer needle so that the catheter distal end can beinserted under ultrasound imaging guidance directly into the target site(the proximal end being held by a handle and used by medical personnelto grasp the assembled image guided catheter device with one hand whilereplaceable needles, tools, transducers of different frequencies,optical fibers and the like are inserted in the two or more channels tothe distal end). For example, the image guided catheter can be inserteddirectly through the chest wall, guided to a heart and then into theheart using the introducer needle without having to make entry throughanother means such as through a blood vessel in a human leg or othervein or by using a guide wire as is taught with prior art devices. Ifnecessary, an ultrasound transducer assembly having a longer range andlower resolution may be replaced in real time during the movement of theimage guided catheter assembly with a higher resolution and shortrangetransducer assembly as the target site is reached or used with a highresolution short range optical coherence tomography or plurality ofoptical fibers or other known vision device. Once at the target locationfor a medical procedure, the removable needle or sheath may be removedand replaced with another instrument such as a biopsy needle, MEMSdevice, tissue clasper or biopsy blade among other instruments (tools).

In another embodiment in accordance with one or more aspects herein, amedical device is provided that can comprise one or more ultrasoundtransducers coupled or associated with a syringe element for delivery ofmedication or withdrawal of unwanted fluids at a treatment site. Anexemplary syringe that may be used to replace an introducer needleassembly once the device is at the target site is a needle assembly suchas is described in U.S. Pat. No. 6,592,559 to Pakter et al., which maydeliver multiple needles to multiple sites within the body at the targetsite.

A MEMS device may be deployed via the distal end to help guide upwardsor downwards the needle, syringe or sheath as the catheter is surgicallymoved towards a site of interest. Furthermore, a tool may replace asolid or hollow needle, syringe or sheath once a site of interest isreached using the needle guide.

According to other aspects, at the proximal end of such a device, ananchoring portion may be provided for anchoring the device to a humanbody once the device is image-guided to the diagnosis or treatment siteor alternatively the device may be manipulated by a handle grasped inone hand by the surgeon. The proximal end may also include lockingmechanisms for securing the removable, replaceable imaging transducerassembly and/or a replaceable syringe with another medical device orinstrument of the expendable housing component while the image catheterdevice is in use during a medical procedure.

According to aspects herein, the housing of such a device may be formedfrom one or more of a variety of materials such as silicone, Teflon,polyurethane, PVC, TPX, and/or elastomeric hydrogel. According to someaspects, the housing may be cylindrical in shape and may include, forexample, a catheter or vascular sheath. As will be shown herein, theneedle/instrument channel and an ultrasound transducer channel may bemounted side by side one another or one on top of the other. Theexpendable housing may be tapered at the distal (patient) end or have adome or a window that may be flat and transparent for the ultrasoundtransducer, optical coherence tomography or plurality of optical fibers,once inserted in the imaging transducer channel/lumen or in its ownlumen. According to some aspects, the ultrasonic probe housing may havea lengthwise slot opening at the proximal cross-sectional side allowingits user to freely remove and replace the replaceable imaging transducerassembly while the image guided catheter device is being used during aminimally invasive medical procedure.

According to aspects herein, the imaging transducer assembly maycomprise a forward viewing linear phased array probe with a variablefield of view depending on the specific array and choice of centerfrequency and frequency range. The imaging transducer assembly maycomprise a plurality of ultrasound transducers at the distal end withvariable frequency, variable cross-sectional diameter, and a variablenumber of transducer elements located in a steel or rigid plasticcylinder with a varying outer diameter, for example, wherein theexpendable housing may have two or three different outer diametersduring its length from a large outer diameter surgeon grasp and optionalhandle at the proximal end of the expendable housing to a very smallouter diameter at the distal end, typically referred to herein as thebarrel having a small diameter for just the imaging and instrumentchannels/lumens.

According to aspects herein, the syringe/needle assembly/instrumentlumen may fit a removable variable gauge solid introducer needle, ahollow syringe needle, a sheath or other interventional instruments asdiscussed above once the operating target site is reached. The needle,sheath or tool may be echogenic and comprise a variegated surface bysanding, engraving, etching or wrapping wire of non-allergic materialround the catheter needle or sheath or tool.

These and other aspects of embodiments of an image guided catheterassembly will be discussed with reference to the drawings, a briefdescription of which follows.

In the brief description of the drawings, for drawings FIG. 1A throughFIG. 12I, similar reference numerals are used to denote similar elementsand the first numeral of a reference numeral such a 1XX denotes thefigure in which the element first appears, in this case, FIG. 1. Also,the XX portion of a reference numeral is intended to refer to a similarcomponent in each figure.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings are exemplary and are not intended to limit the dimensionsof the depicted elements to those shown in the drawings. All dimensionsmay vary with the particular application of the image guided catheter orprobe depicted in the several drawings.

FIG. 1A through FIG. 6B depict a disposable assembly comprising a needleguide, and a tab which may be moved circularly round the elongate probehousing to close one half of the needle guide onto the other half sothat a needle (or syringe or other tool) may be placed vertically intothe open needle guide, the needle guide closed about the tool and thetool removed therefrom, for example, vertically, a probe barrelcontaining an ultrasound transducer section and a disposable sheathsection which has a locking tab. A second assembly, not introduced untilFIG. 9A is discussed, comprises the ultrasound transducer assembly, aprobe housing, a sheath and a cable narrowing section and the exitingcable which connects to a processor and display not shown. Theultrasound transducer assembly provides an imaging plane (referred to inearlier patents as an imaging zone) capturing a region of interestoriginating from the transducer array.

FIG. 1A depicts a view of a patient or distal end of an image guidedcatheter device assembly in accordance with one or more aspectsdescribed herein, FIG. 1A showing a replaceable introducerneedle/syringe/instrument channel 103 above a transducer sensor tipchannel 105, the needle/tool guide 103 having a tapered distal tip 104.When a needle protrudes from this distal tip 104, the needle is visiblein an imaging zone (not shown) of the removable, replaceable transducerelement or array within the probe distal end 105 replaceable, forexample, as higher resolution is needed when the access instrumentreaches the operating site. A tab 106 is shown for use by a surgeon toopen or close the needle guide 103 for insertion of a needle/syringe orother tool. Body or sheath 102 may comprise additional lumen or channelsand may comprise a sensor channel or lumen 105 for additionalneedles/tools (not shown) and may contain leads to the transducer arraybehind tip 105 that form a cable to a processor and display (not shown).A locking tab 101 is provided for permitting insertion of a probe,transducer and cable assembly which may comprise a linear phased arraytransducer assembly having a collection of leads to each piezoelectricelement which form a cable (not shown) but exiting at the rear of sensorchannel 102 to a section first shown in FIG. 9A. Button tabs 107 and108, when needle guide 103 is in an open position, serve to push up on aneedle, syringe or tool in the needle guide 103 so as to release it (forexample, if the needle comes in contact with a sticky substance such ascoagulated blood). Tab 106 will be seen to be used to lock two halves ofneedle guide 103 together.

FIG. 1B depicts a top view of a needle guide 103 of FIG. 1A to show howguides 121 and 122 guide a needle or tool into a needle channel and canrest on needle buttons 107A and 108A of one side of the needle guide 103and also rest on needle buttons 108A and 108B of the other side of theneedle guide.

FIG. 1C depicts an open front view of the needle guide 103. A needle(syringe or tool) may be moved out of the guide sides shown due toopening guides 121 and 122. Button tabs 107A and 107B along with buttontabs 108A and 108B help extricate the needle from the needle guide 103from above.

FIGS. 2A and 2B depict different cross-sectional views of the patient ordistal end of the embodiment of FIG. 1 where tab 106 for closing theneedle channel is now referenced as tab 206 for opening the needlechannel 203 of an imaging device in accordance with one or more aspectsdescribed herein. When tab 206 is manipulated in a clockwise directionround the elongated housing's cylindrical body, the needle channel isclosed around a needle/syringe/tool (not shown). FIG. 2B showsadditional button tabs 209, 210 which may be used or not used in a givenembodiment to further serve to support a needle/syringe/tool in needlechannel tabs (FIGS. 1B and 1C). Needle channel tip 204 is tapered andmay receive and permit a tapered tip hollow needle (possibly of asyringe) to exit the needle guide at tip 204. Sensor channel tip 205 mayindicate the location of an ultrasound sensor not seen which may bedirected forward and provide forward-imaging of a needle/syringe/tool inthe needle channel 203. In either figure, a rear tab 101, 201 may lock asensor and cable section assembly in place within the body 202comprising a sensor channel (transducer assembly and cabling). Needle1010 and sensor and cable assembly 1006 are first seen in FIG. 10 lockedin place by locking tab 1001.

FIG. 3A provides an enlarged front-end view of the tab 106 now seen astab 306A which may move between positions 309 and 310 to open or closethe needle channel. In FIG. 3A, the needle channel tip 304A is shownclosed.

In FIG. 3B, the needle channel tip 304B is shown open. Similarly, afirst part of the needle channel 321A is shown closed in FIG. 3A, andthe same part of the needle channel 322B is shown open in FIG. 3B.Sensor channel 302 of either FIGS. 3A and 3B carries the sensor andcable to the sensor channel tip 305. A second part of the needle channel322A or 322B remain stationary where line 320 represents the line alongwhich the needle channel opens. Section A-A extends from the top of theneedle channel through the sensor body 302.

FIGS. 4A and 4B depict details of the opening and closing of a needlechannel using tabs 106 where FIG. 4A represents a closed needle channeland FIG. 4B represents and open needle channel, for example, wherepartial circular sections connected to tab 106 comprise line 420 alongwhich the needle channel opens. FIG. 4A comprises closed needle channeltip 404A, the first part 421A of the closed needle channel, the secondpart 422A of the closed needle channel, and the sensor channel tip 405of the ultrasound sensor channel. Referring to FIG. 4B, sensor channeltip 405 is in the center. Surrounding this center 405 are open needlechannel tip 404B, open second part 422B of the needle channel and openfirst part 421B of the needle channel. Section C-C is taken just of theprobe housing as seen in FIG. 1A.

FIGS. 5A and 5B depict in rear perspective view a closed needle channel504A (FIG. 5A), button tabs 507, 508, and closed needle entry 503A (FIG.5A) leading to distal closed tip 504A (FIG. 5A) of the needle channelsensor channel tip 505 (seen in both FIGS. 5A and 5B). The sensor body502 in both figures has a tab 501 for allowing a sensor probe and cableto be placed within the housing per FIG. 10. Closing tab 506A in FIG. 5Ashows a close position for the needle guide while closing tab 506B inFIG. 5B shows an open position for the needle guide as per open needleguide 503B. Distal tip 504A is shown closed in FIG. 5A and open tip 504Bis shown in FIG. 5B. Circle D shows the difference between closed needleguide 503A (FIG. 5A) and open needle guide 503B (FIG. 5B) where openingand closing uses tabs 506A (closed) and the same tab 506B in an openposition.

FIGS. 6A through 12I show an embodiment similar to the previouslydiscussed embodiment whereby a sleeve lock is used to lock two halves ofa needle channel of a needle guide together around an inserted tool: forexample, a needle, syringe or other tool.

FIGS. 6A and 6B depict front perspective views of the line 620 alongwhich the needle channel 603 opens along with a portion of the sensorhousing or body 602. Referring to FIG. 6A needle channel 603A is in aclosed position, the first part of the needle channel 621A is closed asis the second part (for example, half) of the needle channel 622A.Referring now to FIG. 6B, the needle guide is in an open position 603Band the first and second parts 621B and 622B (for example, halves) ofthe needle channel are opened.

Thus far, we have discussed how a tab 106 may open and close a needlechannel. In FIGS. 7A through 8H and in FIG. 9A an alternative to a tabclosure is shown that comprises a sliding groove 724 moved by a surgeonvia a circular or partially circular tab or sleeve lock 723 withunnumbered finger grips seen as rounded gripping ridges on the sides ofthe sleeve lock 723.

FIG. 7A shows sensor housing channel 702 and the needle channel 703 in aclosed position where the circular tab or sleeve lock 723 and groove725A have been slid forward to clasp the two halves of a needle guide703 together. The groove may have parallel sides shown or have V-shapedclasping sides. The parallel sides 721 and 722 (FIG. 7B) of groove 724may have a corresponding quarter-circular portion 725A which gathers thetwo sides 721, 722 of the needle guide together, and the groove 724holds the needle guide together. A retaining spring tab 712 retains thesleeve lock so as to close the needle channel 703 of the needle guide.

In FIG. 7B, it may be seen that a matching quarter-circular portion 725Bmatches portion 725A and so, when they meet as the tab 723 is closed,the two sides 721, 722 of the needle guide 703 are caused to collapseand be held by together by the groove 724 via sleeve lock 723 as seen inFIG. 7A.

FIG. 8A depicts a top down view of the groove closure of FIGS. 7A and7B. As already seen, sensor housing 809 has a locking tab 801 forlinking with a sensor and cable assembly seen in FIG. 10. Needle guide803 is seen held closed in a groove and is so held in a closed positionas long as the groove grips the halves of the needle guide 803 together.Retaining tab 812 holds sleeve lock 823 closed also closing needlechannel 803.

FIG. 8B provides a side cross-sectional view of the sensor and needleguide assembly shown in top view in FIG. 8A. Sensor 802 has a lockingtab 801 for linking to an internal transducer and cable assembly perFIG. 10 as seen in FIG. 8A in top view. Needle guide 803 is shown closedwith button tabs 807 and 808. Retaining tab 813 prevents a sleeve lock823 from opening any further than its raised edge.

FIG. 8C depicts an expanded view of the closing groove mechanism (DetailB) for closing the needle guide first and second parts 821 and 822 alongline 820 via quarter-circular groove portions 825A and 825B so thatsleeve lock 823 in a forward position closes the needle guide within thedepicted groove 824.

FIG. 8D shows a side view similar to the side cross-sectional view ofFIG. 8B. The sensor channel 802 is seen at the distal end and the tab801 at the proximal end. The finger grip 823 is shown extended so as toforce the needle channel 803 closed with button tabs 807 and 808.

FIG. 8E is a front perspective view of the sensor housing of FIG. 8D. Anultrasound sensor channel 802 is located below the needle channelindicated by button tabs 807 and 808 and needle guide opening 803. Theneedle channel 803 is closed by a sleeve lock 823 and retained in aclosed position by retaining tab 812, the sleeve lock 823 having fingergrips as seen and a groove (not visible) which holds the halves of theneedle guide 803 together. Also shown are a disposable plastic sheath809 and locking tab 801 for locking together with a sensor and cableassembly seen in FIG. 10. Circle D will be described in FIG. 8F.

FIG. 8F provides an expanded view (Detail D) of the sleeve lock 823showing needle guide halves 821, 822 held together in a groove 824facilitated by quarter-circular section 825A.

FIG. 8G shows a rear perspective view of the needle guide and sensorhousing with locking tab 801, needle guide 803, button tabs 807, 808,sensor housing 803, quarter-circular section 825A of a gripping grooveof sleeve lock 823 held in closed position by retaining tab 812 anddisposable plastic sheath 809. Circle C will be described with referenceto FIG. 8H.

FIG. 8H provides a rear expanded perspective view of the closure ofneedle guide 803 (Detail C) having halves 821 and 822 within a groove824 of sleeve lock 823 having a quarter-circular section 825A formatching with needle guide quarter-circular section 825 along closureline 820.

FIG. 8I provides a cross-section of the disposable plastic sheathportion including sheath 809, the needle channel distal tip 804 and thesensor channel tip 805 which may comprise a window for an internalultrasound transducer assembly (not shown).

FIGS. 9A through 9I provide views of a combination assembly of thesensor housing and needle guide section with the sensor and cablingsection using the groove needle guide locking mechanism or sleeve lock923 as discussed above. Alignment of the imaging plane 919 (or zone ofreflected imaging) with the needle delivery port of the needle guide 903permits ultrasound visibility of the needle/syringe/tool or other devicewithin the imaging plane when these are introduced subcutaneously into apatient.

FIG. 9A provides a top view of the combination assembly comprising fromleft to right sensor channel tip 905 with a needle guide tip directlyabove but not easily discernable. Sensor channel 902 holds, for example,a probe comprising a linear phased array with each element connected toleads of a cable (not seen) until the cable exits at right as cable906A. An imaging plane or zone is seen surrounding the linear phasedarray within a range around the center frequency. Alignment of theimaging plane with the needle delivery port portion of the sheathpermits ultrasound display of an emerging needle/biopsyneedle/syringe/other tool of needle guide 903. Needle guide 903 is shownclosed within a groove of circle B. Gripping tab 923 that may slide backis shown closed and retained by retaining tab 912 so that a groovecloses needle guide 903. Next to the right is disposable sheath 909 anda cable joining section 906B of a probe, probe housing and cableassembly.

FIG. 9B is a cross-section along line A-A of FIG. 9A so as to see theinternal components of the combination assembly. A right-sidecross-section of the assembly comprises from right, cable 906A whichmerges with cable joining section 906B and the individual piezoelectricelement leads (from each element may be combine to form a cable) maypass through sections 906B and 906C (a probe section) to, for example, alinear phased array of elements facing forward at sensor tip 905. Tab901 locks needle guide section 902, 903, 904, 907, 908, along with cablesection disposable housing 909 to the internal cable and sensor sections906A, 906B and 906C.

FIG. 9C is a further exploded top view (Detail B) of the needle guidelocking mechanism comprising along closing line 920 a firstquarter-circular groove section 925A and an opposite quarter-circulargrove section 925B of groove 904 of sleeve lock 923 which close aroundneedle guide halves 921 and 922 to close the needle guide 903.

FIG. 9D is a complete assembly side view comprising from left to right asensor tip 905, a sensor housing 902, needle guide button tabs 907 and908 and needle guide 903. The sleeve lock 923 is seen in a closedposition so that needle guide 903 would be closed. Disposable plasticsheath 909 is seen next with tab 901 holding sensor and cable assembly906A and 906B in place, mostly internally within the housings 902 and909.

FIG. 9E provides a front perspective view of the entire assembly.Starting from left is seen the sensor housing tip 905, the probe housing902, needle guide button tabs 907, 908, the needle channel 903 withsleeve lock 923 having quarter-circular section 925A for locking theneedle guide 903 in a groove of sleeve lock 923 in a closed position(Circle D discussed in FIG. 9F) held by retaining tab 912, disposableplastic sheath section 909 (covering cable) and ultrasound sensor andcable sections 906B and cable 906A may be seen. When sleeve lock 923 ismoved to the rear opening the needle channel 903 via the sleeve lock923, the sleeve lock 923 is retained by a retaining tab on the bottom ofsheath 909. A forward-directed linear phased array would be located justbehind sensor tip 905, and the array provides an imaging plane which maybe aligned with the needle guide delivery port portion of the sheath ofthe needle guide 903 for displaying in real time a position of aneedle/syringe/tool emerging from the needle guide and usedsubcutaneously. An approximately two-dimensional ultrasound imagingplane 919 is shown to be oriented perpendicular to the face of theultrasound array to the center of the needle port delivery port portionof the sheath; (see also FIG. 9I). This ensures that during a procedurethe needle or other tool emerging from the needle guide 903 at itsdistal port is automatically visible in the ultrasound image without thephysician needing to adjust the relative orientation of a sheath orultrasound probe.

FIG. 9F provides a front perspective view of the needle guide lockingmechanism in a closed position along line 920 (Detail D). Sleeve lock923 locks needle guide halves 921 and 922 together in a groove 924having a quarter-circular section 925A and a rear groove face 926A andis retained in closed position by retaining tab 912 (FIG. 9E).

FIG. 9G provides a rear perspective view of the combination assemblyfrom left to right comprising the sensor housing tip 905, the probehousing 902, needle guide button tabs 907, 908, the needle channel 903with sleeve lock 923 having quarter-circular section 925A for lockingthe needle guide 903 (in circle C) in a groove of sleeve lock 923,disposable plastic sheath section 909 (covering cable) and ultrasoundsensor and cable sections 906B and cable 906A may be seen along with tab901 for holding the outer housing together with the probe and cableassembly. A forward-directed linear phased array would be located justbehind sensor tip 905 and the array provides an imaging plane 919 whichmay be aligned with the needle guide delivery port portion of the sheathof the needle guide 903 for displaying in real time a position of aneedle/syringe/tool emerging from the needle guide and usedsubcutaneously.

FIG. 9H is an exploded view of Detail C where needle guide halves 921,922 of needle guide 903 are held together by a groove 924 of sleeve lock923.

FIG. 9I is very similar to FIG. 8I and shows a cross-section of thedisposable plastic sheath portion 909, the needle channel tip and thesensor channel tip 905, the needle channel tip being the end portion ofthe needle guide 903. The exact orientation of the ultrasound imageplane 919 is shown to intersect the center of the imaging array andneedle delivery port, thereby ensuring that the needle or other toolbeing delivered will be visible in a processed ultrasound image (notshown) without the physician having to adjust the relative position ofthe sheath or ultrasound probe.

FIGS. 10A through 10I depict several views of the above-described needleguide embodiment and probe and cable assembly also including anexemplary needle having a handle 1010 and a tip 1011. The needle 1011and handle 1010 are shown in the needle channel 1003. The needle 1010,1011 may be a biopsy needle and be hollow for collecting tissue at asite of interest located by forward-imaging of a transducer arraylocated behind sensor tip 1005. Retainer tab 1012 retained sleeve lock1023 in a closed position.

FIG. 10A shows section A-A seen in FIG. 10B. FIG. 10A from left to rightincludes but is not limited to showing needle tip 1011, closed needleguide 1003, sleeve lock 1023, needle handle 1010, circle B forexplaining the locking mechanism, disposable plastic sheath section1009; letter A where the clasp 1001 would be located on the undersideand is not visible, cable narrowing section 1006B and cable section1006A. Needle handle 1010 may comprise a syringe.

FIG. 10B shows section A-A comprising from left to right a needle tip1011, button tabs 1007 and 1008 which assist in lifting needle 1011 (orother tool) vertically out of the needle channel 1003, sensor tip 1005,probe 1006C, piezoelectric element signal leads 1002 (from arrayelements to form a cable), needle handle 1010, locking tab 1001 in thevicinity of A of FIG. 10A, cable narrowing section 1006B and cablesection 1006A from which a cable exits a proximal end toward a processorand display (not shown).

FIG. 10C provides an expanded view of detail B (circle B of FIG. 10A)showing the needle channel halves 1021, 1022 in a locked position ingroove 1024 having been guided into groove 1024 by quarter-circularedges 1025A, 1025B of the distal end of groove 1024. FIG. 10C also showsneedle handle 1010 and a top viewable portion of locking sleeve 1023.

FIG. 10D is a side view of a complete assembly including both a probeand cable housing portion 1005, 1002, 1009, a locking sleeve 1023 heldin a closed position by retaining tab 1012, a needle 1011 and handle1010 held in needle channel 1003 by button tabs 1007, 1008 and adisposable sheath 1009 having a retaining tab 1001 for securing a cableand probe section 1006A, 1006B. Retaining tab 1013 stops sleeve lock1023 from moving rearwards along sheath 1009.

FIG. 10E provides a front perspective view of a complete assembly asseen in FIG. 10D comprising four components, a needle 1011 and needlehandle 1010, the needle residing in a needle channel 1003 of a needleguide, the needle 1011 supported by button tabs 1007 and 1008 of theneedle guide portion of a probe and cable housing comprising the needleguide, a distal probe tip window 1005, a probe housing 1002 and adisposable sheath 1009 having a locking tab 1001 for locking, forexample, a probe containing a linear phased transducer array locatedbehind the window 1005, and element leads to a cable exiting the sheath1009 via cable narrowing section 1006B while cable 1006A leads to aprocessor and display (not shown) and the sleeve lock 1023 which is sliddown sheath 1009 and over retaining tab 1012 to close needle channel1003 over needle 1011. Circle D will be discussed with reference to FIG.10F.

FIG. 10F provides an expanded view of detail D (circle D of FIG. 10E)showing the needle channel halves 1021, 1022 in a locked position ingroove 1024 having been guided into groove 1024 by quarter-circularedges 1025A, 1025B (not visible) of the distal end of groove 1024joining the two halves 1021, 1022 of needle channel 1003. FIG. 10F alsoshows needle handle 1010 and a top viewable portion of locking sleeve1023.

FIG. 10G provides a rear perspective view of a complete assembly as seenin FIG. 10D comprising four components, a needle 1011 and needle handle1010; the needle 1011 residing in a needle channel 1003 of a needleguide, the needle 1011 supported by button tabs 1007 and 1008 of theneedle guide portion of a probe and cable housing comprising the needleguide, a distal probe tip window 1005, a probe housing 1002 and adisposable sheath 1009 having a locking tab 1001 for locking, forexample, a probe containing a linear phased transducer array (not shown)located behind the window 1005, and element leads to a cable exiting thesheath 1009 via cable narrowing section 1006B while cable 1006A leads toa processor and display (not shown) and the sleeve lock 1023 which isslid down sheath 1009 during assembly and over retaining tab 1012 toclose needle channel 1003 over needle 1011. Circle C will be discussedwith reference to FIG. 10H.

FIG. 10H provides an expanded view of detail C (circle C of FIG. 10G)showing the needle channel halves 1021, 1022 in a locked, closedposition in groove 1024 having been guided into groove 1024 byquarter-circular edges 1025A, 1025B (not visible) of the distal end ofgroove 1024 joining the two halves 1021, 1022 of needle channel 1003.FIG. 10H also shows needle handle 1010 and a top viewable portion oflocking sleeve 1023.

FIG. 10I is very similar to FIGS. 81 and 9I but differs in showingneedle tip 1011 emerging from needle guide 1003 and shows across-section of the disposable sheath portion 1009, the needle channeltip 1004 and the sensor channel tip 1005 with the end portion of theneedle guide 1003.

FIG. 11A provides a top view of a complete assembly of an image guidedcatheter or probe 1100 as seen also in FIG. 10E with sleeve lock 1123open comprising four components, a needle 1111 and needle handle 1110,the needle still residing in a needle channel 1103 of a needle guide,the needle 1111 supported by button tabs (not visible) of the needleguide portion of a probe and cable housing comprising the needle guide,a distal probe tip window 1105, a probe housing 1102 and a disposablesheath 1109 having a locking tab (not visible) for locking, for example,a probe containing a linear phased transducer array located behind thewindow 1105, and element leads to a cable exiting the sheath 1109 viacable narrowing section 1106B while cable 1106A leads to a processor anddisplay (not shown) and the sleeve lock 1123 which is slid down sheath1109 and over retaining tab (not visible) to close needle channel 1103over needle 1111 via groove 1124. Circle B will be discussed withreference to FIG. 11C. Cross-section A-A will be discussed withreference to FIG. 11B.

FIG. 11B provides a cross-section view of a complete assembly along A-Aof FIG. 11A and comprises four components, a needle 1111 and needlehandle 1110, the needle 1111 residing in a needle channel 1103 of aneedle guide, the needle 1111 supported by button tabs 1107, 1108 of theneedle guide portion of a probe and cable housing comprising the needleguide located at the top, a distal probe tip window 1105, a probehousing 1102 and a disposable sheath 1109 having a locking tab 1101 forlocking, for example, a probe containing a linear phased transducerarray located behind the window 1105 seen as section 1106C, and elementleads (not shown) to a cable section 1106A exiting the sheath 1109 viacable narrowing section 1106B while cable 1106A leads to a processor anddisplay (not shown) and the sleeve lock 1123 which is slid down sheath1109 and over retaining tab 1113 to close needle channel 1103 overneedle 1111 via groove 1124. The needle channel 1103 is open and sheath1123 has not been moved toward the distal tip 1105 to close the needlechannel 1103.

FIG. 11C provides an expanded view of Detail B of FIG. 11A showing theneedle channel open and comprises the needle channel halves 1121, 1122in an open, unlocked position outside groove 1124 having been releasedfrom groove 1124 and quarter-circular edges 1125A, 1125B of the distalend of groove 1124 releasing the two halves 1121, 1122 of needle channel1003 to expose to view needle 1110 with its handle 1111 also visible.FIG. 11C also shows needle handle 1111 and a top viewable portion oflocking sleeve 1123.

FIG. 11D provides a side view of the complete assembly of four partswith the needle channel 1103 open but the needle 1111 and needle handle1110 still residing in the needle channel. Locking sheath 1123 has beenmoved toward the proximal end to be stopped by retaining tab 1113. Fromleft to right, imaging window 1105 of probe housing 1102 has mountedthereon a needle guide comprising button tabs 1107, 1108 supportingneedle 1111 in needle channel 1103. At the end of needle channel 1103 isseen a quarter-circular edge of the channel which mates withquarter-circular edge 1125A of groove of open sheath 1123 when closedbut, when open, locking sheath 1123 rests against retaining tab 1113 andsurrounds sheath 1109. Locking tab 1101 locks in probe and cableassembly comprising a cable narrowing section 1106B leading to cable1106A.

FIG. 11E is a front perspective view of a complete assembly with theneedle channel 1103 open and the needle 1111 and needle handle 1110 areexposed and are supported on button tabs 1107 and 1108 of the needleguide. From left, the probe housing tip or window 1105 is seen on probehousing 1102 while sleeve lock 1123 is shown open on disposable sheath1109. Locking tab 1101 locks probe and cable section within comprisingvisible cable narrowing section 1106B and cable 1106A. Circle D will bedescribed with reference to FIG. 11F. Needle handle 1110 may comprise asyringe having two cylindrical sections.

FIG. 11F is an expanded view of detail D of FIG. 11E showing the needlechannel halves 1121, 1122 open exposing to view needle 1111 and needlehandle 1110 and comprises the needle channel halves 1121, 1122 in anopen, unlocked position outside groove 1124 having been having beenreleased from groove 1124 and quarter-circular edges 1125A, 1125B of thedistal end of groove 1124 releasing the two halves 1121, 1122 of needlechannel 1103 to expose to view needle 1111 with its handle 1110 (whichmay comprise a syringe) also visible. FIG. 11C also shows needle handle1110 and a top viewable portion of locking sleeve 1123.

FIG. 11G is a rear perspective view of the complete assembly with theneedle channel 1103 open and the needle 1111 and needle handle 1110 areexposed and are supported on button tabs 1107 and 1108 of the needleguide. From left, the probe housing tip or window 1105 is seen on probehousing 1102 while sleeve lock 1123 is shown open on disposable sheath1109. Locking tab 1101 locks probe and cable section within, the sectioncomprising visible cable narrowing section 1106B and cable 1106A. CircleC will be described with reference to FIG. 11H. Needle handle 1110 maycomprise a syringe having two cylindrical sections, one for holdingfluid and a pull handle for withdrawn fluid through needle 1111.

FIG. 11H is an expanded view of detail C of FIG. 11G showing the needlechannel halves 1121, 1122 open exposing to view needle 1111 and needlehandle 1110 and comprises the needle channel halves 1121, 1122 in anopen, unlocked position outside groove 1124 having been having beenreleased from groove 1124 and quarter-circular edges 1125A, 1125B of thedistal end of groove 1124 releasing the two halves 1121, 1122 of needlechannel 1103 to expose to view needle 1111 with its handle 1110 (whichmay comprise a syringe) also visible. FIG. 11H also shows needle handle1110 and a top viewable portion of locking sleeve 1123.

FIG. 11I is a top perspective expanded cross-sectional view showing openneedle channel 1103 comprising needle channel halves 1121 and 1122 in anopen position. Needle 1111 has handle 1110 shown still inside the needleopen channel 1103 comprising halves 1121 and 1122. FIG. 11I furthershows cross-section 1109 of disposable sheath 1109 and the probe windowor distal probe housing end 1105.

FIGS. 12A through 12I are identical to FIGS. 11A through 11I but for themovement of needle 1211 (or other tool) and handle 1210 (or syringeportion) vertically out of the needle channel 1203 and will not bedescribed in any detail to avoid redundancy. However, FIG. 12I will bebriefly explained as it shows the needle 1111 removed from the channelvertically.

FIG. 12I shows needle handle 1210 and needle 1211 removed vertically andoutside the open needle channel comprising open needle channel halves1221 and 1222. Probe distal end 1205 is seen as is the sheath section1209 in cross-section.

FIGS. 13 through 17B provide an overview of the insertable probe, cableand linear phased array transducer assembly 1006A, 1006B, 1106C, that islocked by locking tab 101, 201, 501, 801, 901, 1001, for example, insidedisposable sheath 102, 202,502, 909, 1009, for example.

FIG. 13 present provides a side view at its center of a pluralityultrasonic elements (not visible) of a transducer probe according to thepresent invention which may have a protective sheath (not shown)disposed between the probe 1361 located toward the distal tip 1360. Alldistances if any are shown are approximate and may be changed fordifferent applications such as reaching the heart pericardial sac (alsoknown as the pericardial space) versus reaching a melanoma close to theskin or a kidney with an anterior approach with optimized resolution andare shown in millimeters. A convention used in the brief and detaileddescription is that a reference numeral YXX may be used wherein the Yprovides the Figure number where the element first appears and the XX(which may be any two-digit number) may represent the reference numeralof the element (used consistently for a similar component), for example,transducer array 1362 comprises Y for FIG. 13 and XX for numeral 62which represents the transducer array while element 1310A represents thecylindrical housing 1310A shown in FIG. 12 held within disposablesheath, for example, 1109 by a surgeon (not shown in this figureseries). To the left of FIG. 13, is seen a cross-section of a plane ofhousing 1310A including both the probe 1361 and the cylindrical housing1310A. At the right of FIG. 13 is shown a cross-section 1340 intended toshow the radially placed elements of the outer cylindrical housing1310A, cable transition portion 1206B, the strain relief feature and thecable 1206A including, for example, the twenty-three leads to thetransducer linear phased array, shown by way of example, which in turnleads to a display processor and display. Views 1361, 1362, 1316 areshown enlarged as FIGS. 14A (end view) and 14B (cross-sectional topview) of exemplary linear phased array elements 1462-1 through 1462-23.

FIG. 14A shows a first exemplary embodiment of a front view of anexemplary ultrasound linear phased array having, for example,twenty-three linear elements 1462-1 through 1462-23 of, for example, 0.1millimeters pitch (approximately one lambda wavelength of an exemplarycenter frequency of fifteen megahertz) making a total array 1362, 1462of about 2.3 millimeters by 2.3 millimeters. A ½ λ embodiment may alsobe used as is known in the art with the complication that the number ofelements of the array may increase the size of a cable to a processorand display (not shown). Not shown in FIG. 14A or distal tip 1360 ofFIG. 13 is that the linear phased array may be protected within a dome,flat window, no window, or tapered window of the housing including theneedle guide and when actuated generates an image plane discussed abovewith intersects with a needle delivery port of a needle guide so as tocapture an image of any needle/syringe/sheath/tool emerging into theimaging plane. A probe shaft cylindrical housing 1410A (FIG. 14B) isseen that may have a circular cross-sectional shape that isapproximately four millimeters in diameter as seen in FIG. 13. Notshown, the probe shaft cylindrical housing 1410A may contain electricallea-ds to the linear phased array transducer array 1362 and anaccelerometer and/or one or more gyroscopes having signal leads whichwill align any image on a display with the gravitational field of theearth. One transducer array may be replaced with another transducerarray having a different center frequency and similar one lambda pitchand still fit within the outer probe housing diameter, for example, fourmillimeters. A more conventional ½ λ pitch may be used in alternativeembodiments, a possible problem being the number of diameter of leadsforming a cable from the distal to the proximal end of the catheter. Thearray 1362 may comprise individual linear phased array transducerelements comprising a one by twenty-three linear array shown as elementsindividually numbered 1462-1 through 1462-23. The white area between thelinear phased transducer array 1362 and the housing 1361 is un-numberedand comprises a potting material 1464 seen best in top-down cut-awayview FIG. 14B. As described above these array elements 1462-1 through1462-23 for different center frequency may be contained within a probeinsertable into a disposable outer housing, FIGS. 1 through 12I so thattransducer arrays may be exchanged for different applications of theprobe.

FIG. 14B shows a top sectional 1460 comprising the distal tip and, inparticular, comprises from left to right a cross-hatched probe shafthousing 1410A, an array potting material 1464 to firmly grasp the linearphased array elements 1462-1 through 1462-23 (FIG. 14A). Below thesection 1460, there is seen at the center of the probe shaft housing1410A, an aperture for conducting an electrical signal cable 1465,narrowing the signal cable 1465 from the diameter of cable channels topiezoelectric elements 1462, the leads carrying signals to/from thelinear phased array elements 1462-1 through 1462-23 via the arraybacking 1463. The aperture is preferably walled as shown and extends theentire length of the probe shaft housing, carrying the electrical cable1465.

FIG. 15A is a blow-up of the left side cross-section of FIG. 13. Thereis a section labeled 1216 intended to represent a thicker portion of thehollow cylindrical housing 1310A of FIG. 13. A pair of broken lines,perpendicular to one another signifies the center of the cylindricalhousing 1310A. Similarly, a pair of solid lines perpendicular to oneanother signifies the center of the probe shaft housing in circle A suchthat the distance between the two centers may be approximately sixmillimeters and the diameter (shown as a single line and arrow tip) ofthe cylindrical housing 1310A may be approximately 17.5 millimeters.

FIG. 15B is a blow-up of detail A of FIG. 15A showing the relationshipbetween the linear phased transducer array 1462, its probe shaft 1461which may comprise potting material 1464 and the outer wall 1416 of thecylindrical housing 1310A. The partial circular line is intended to showthat wall 1416 only represents a portion of cylindrical housing 1310Aand should not be considered a part of the image guided probe which maybe reusable and removable from the outer sheaths depicted in Figuresdescribed above.

FIG. 16 provides either a top-down view or a bottom-up view of the imageguided probe at the center of FIG. 13 (without showing details of anysheath for protecting the probe so that the probe housing is reusable).The view shows the probe 1350's distal end 1360 where would be locatedthe linear phased transducer array 1462 of the present invention. Thecenter section is the cylindrical housing 1310A that is covered by adisposable sheath that may be grasped and utilized by a surgeon. Thesection transition feature 1315 provides a side view of an exampletransition between the probe's cylindrical cable housing 1310A and thecable strain relief feature 1306B which provides the exit of cable 1306Afrom the imaging probe for image processing and display.

FIG. 17A is a left front perspective view of an image guided probecomprising distal probe end 1360, probe shaft 1350, cylindrical housing1310A, transition feature 1315, flexible cable section 1306B and cable1306A from left to right.

FIG. 17B is a right rear perspective view of an image guided probeshowing the same components in the same order as is seen in FIG. 17Afrom upper left to lower right.

These and other echogenic shapes of needles, sheaths and tools forimaging in parallel via a parallel ultrasound transducer are describedin U.S. provisional patent application Ser. No. 62/526,170 filed Jun.28, 2017, incorporated by reference as to its entire contents. Imagingmay also be improved using a known contrast agent during a procedure ifthe needle, syringe, sheath or tool penetrates the skin tissue so thatblood vessels may preserved from puncture as a tool is guided toward aregion of interest.

Thus, there will be described in the following detailed description aplurality of embodiments and features of an image guided catheter orprobe of the present invention with removable, replaceable and reusableimaging assemblies and removable, replaceable instruments for performingminimally invasive medical procedures as will be explained furtherherein.

DETAILED DESCRIPTION

The aspects summarized above can be embodied in various forms. Thefollowing description shows, by way of illustration, combinations andconfigurations in which the aspects can be practiced. It is understoodthat the described aspects and/or embodiments are merely examples. It isalso understood that other aspects and/or embodiments can be utilized,and that structural and functional modifications can be made, withoutdeparting from the scope of the present disclosure.

Minimally invasive procedures provide physicians with access to internalorgans and structures via a small number of incisions in the patient'sbody. Minimally invasive procedures are generally preferable over openprocedures because they require only small incisions, thus reducingtrauma to the body, lessening recovery time, and reducing costs. Themedical instruments used in performing such procedures are generallysimilar to those used in open surgical procedures except that theyinclude an extension such as a tubular extension of small outer diameterbetween the patient end of the instrument entering the surgical field(i.e., the operable end of the tool, instrument or device) and theproximal end portion having a large outer diameter gripped by thesurgeon, the tubular extension at the distal or patient end beingtapered or having a viewing dome and containing an imaging assemblylumen and at least one other lumen, for example, for an introducerneedle having a solid pointed tip, a biopsy or other needle, sheath,syringe or other tool or instrument of various types once the operatingsite is reached.

Typically, minimally invasive procedures may involve up to fiveincisions up to one inch in length. The treatment area is then accessedby inserting one or more cannulas or sleeves through the incisions toprovide entry ports through which instruments are passed. Alternatively,access to the treatment area can sometimes be obtained using a naturalbody opening such as the throat, nose, ear canal or rectum or via avein. In procedures using this approach, a cannula or sleeve may beinserted into the bodily opening and surgical instruments are passed tothe treatment site, either through the cannula/sleeve or directlythrough the body opening or vein.

While minimally invasive procedures provide numerous advantages overopen procedures, they generally do not provide a physician with a directview of the targeted sites. Further, many parts of the anatomy arerather complex and/or small and thus require particular precision anddelicate handling. It is therefore desirable to provide precise imagingtechniques for use during minimally invasive procedures.

In general, the illustrated embodiments and aspects provide an imageguided catheter/probe device that couples an imaging system within animaging lumen and an instrument delivery system and/or minimallyinvasive interventional device within a further lumen or channel (suchas the needle channel 103 of FIG. 1) open from the proximal end to thetapered or flat distal end. The instrument delivery system can include,for example, delivery of materials to or from a target site or deliveryof instruments and devices to a target site, depending on theapplication.

In accordance with aspects described herein, an ultrasound imagingdevice of this invention can comprise one or more small ultrasoundtransducers integrated into an imaging transducer assembly exemplifiedby a linear phased transducer array, either as forward-directedtransducers for direct, head-on imaging or combined with one or moreside-directed transducers (as taught in priority patent applications andissued patents of inventor Dr. Abraham) which can provide additionalimaging or other ultrasound applications such as delivery of heat to atarget site within the patient. In addition, such ultrasound imaging canalso be combined with all-optical high-resolution transducer imagingsuch as optical coherence tomography imaging and/or provide optionaloptical imaging through the use of one or more fiber optic bundlesdisposed though the imaging transducer probe and cable assembly inadditional imaging lumens (not shown) but discussed in priorityapplications and patents.

For example, a first low resolution, long range ultrasound imagingtransducer assembly may be used with an introducer needle tosubcutaneously enter a patient. This assembly may be replaced with ahigher resolution, short range imaging transducer assembly as the targetsite is reached in real time. Once the site is reached, a further highresolution, short range assembly may be introduced through the imaginglumen or channel which may comprise an optical coherence tomographydevice which operates on an echo principle similar to that employed byultrasound. One or more minimally invasive medical procedureapplications will be discussed herein.

An imaging system in accordance with aspects and features describedherein can guide and facilitate many different procedures, therebysignificantly assisting in the access of and performance of procedureson organs, structures and cavities within the body, particularly duringminimally invasive procedures. The described devices and methods arecompatible with all surgical and diagnostic devices and will allowbedside emergency procedures. Ultrasound provides particular benefitsbecause it is biologically safe and uses non-radiating energy to providedetailed anatomic and, in some cases, functional images. The imagesgenerated by devices described herein can provide a user with directvision within the body in real time. Further, both ultrasound andoptical coherence tomography provide a user with visualization ofstructures as well as within and beyond nearby structures (such as thepericardium) to perform procedures such as a cardiocentesis.

In certain embodiments, the device may comprise an ultrasound imagingcatheter/probe that incorporates one or more variable frequencyultrasound transducer assemblies that replace an original transducerassembly operating at one or more frequency ranges within the frequencyrange of from twenty kilohertz to, for example, several hundredmegahertz; (however, the wavelength of such a low frequency may requirethe probe housing to have a large diameter unsuitable for subcutaneousprobe insertion). Optical coherence tomography may provide furtherimaging at radio frequencies, for example, in the infrared. In onepreferred embodiment, one selected frequency range of one replaceabletransducer assembly of a center frequency may be from ten to fortymegahertz (fifteen megahertz center frequency shown). However, variousfrequency ranges of the replaceable ultrasound transducer assembly canbe used for different purposes and provide different beneficial results.Frequencies in the lower range, for example, below one megahertz, andparticularly in the 100 to 200 kilohertz range, can be used, forexample, to provide heat therapy or to treat conditions such as bloodclots and provide low resolution, long range imaging. Frequencies aboveone megahertz can be used to provide higher resolution, short rangeimaging. For example, frequencies in the 25 to 30 megahertz range can beused to image organs such as the eye or can be used to provide imagingof small animals. Even higher frequency ranges, for example, ultrasoundfrequency ranges in the one hundred to several hundred megahertzfrequency range, can be used to provide very high-resolution imaging,sometimes known as high-frequency ultrasound microscopy. This andoptical coherence tomography may achieve sub-micrometer resolution foruse in very close target sites such as at a heart valve with minimallyinvasive surgery replacing prior art open heart surgery. A furtheroperation for placing, for example, for placing a heart pacemaker maynow employ the present invention to place the pacemaker directly on thepericardium rather than utilize a wire and hook device to deliver anelectric pulse to the heart as is now commonly used. Now the imagecatheter devices will be further discussed with respect to potentialapplications.

Devices and methods such as are described herein are suitable for use ina variety of medical procedures. In certain embodiments, the imageguided catheter device may comprise conventional catheter applicationsincluding, for example, biopsy catheters, ablation catheters, andmapping catheters, in combination with the novel imaging aspects ofreplaceable imaging frequencies and instruments imaged by the imagingcomponents described herein. In other embodiments, the device cancomprise one or more interventional devices (e.g. syringe, forceps,biopsy instruments, clamps, MEMS manipulators, retractors, etc.) thatmay be compatible with an imaging catheter/probe such as a biopsycatheter, ablation catheter, mapping catheter, or other form of sheathhaving larger diameter lumens. In some embodiments, the device can alsobe compatible with instruments such as video-scopes, external wired orwireless ultrasound imaging and delivery needles such as those used forstem cell therapy or implanted ultrasound devices which may utilizewireless transmission of ultrasound data for supplemental viewing of asurgical site. In still other embodiments, the devices may be compatiblewith fiber optics such as those used for vision therapy as well asoptical coherence tomography. U.S. patent application Ser. No.11/871,219 filed Oct. 12, 2007 (now U.S. Pat. No. 8,147,413 issued Apr.12, 2012, Ser. No. 12/182,247 filed Jul. 30, 2008 (now U.S. Pat. No.8,038,622 issued Oct. 18, 2011), Ser. No. 12/283,779 filed Oct. 14, 2008(now U.S. Pat. No. 8,147,414 issued Apr. 3, 2012), Ser. No. 12/700,066filed Feb. 4, 2010 (now U.S. Pat. No. 8,235,903 issued Aug. 7, 2012),Ser. No. 13/847,902 filed Aug. 22, 2013 (now U.S. Pat. No. 9,149,257issued Oct. 6, 2016) and Ser. No. 13/973,476 filed Aug. 22, 2013(pending) all by Theodore P. Abraham are incorporated by reference as totheir entire contents, and all medical devices and applicationsdescribed therein may be adapted for use with the present invention and,for example, adapted to fit through the needle/instrument lumen orchannel or other additional lumen (not shown) of the present invention'sexpendable housing part (for example, per FIG. 1A). Furthermore, allother features and functionalities described in all these patentapplications may be incorporated into and may be combined withembodiments of the present invention.

The devices and methods of various embodiments of an imaging cathetersuch as those illustrated in FIGS. 1A-17B and described herein can beused in various minimally invasive surgical procedures and in otherdiagnostic and therapeutic applications. One skilled in the art willappreciate that the aspects and embodiments of an imaging catheter/probeas described herein, although advantageously suited for such procedureson humans, can have other uses, such as for veterinary procedures andopen medical techniques as well as minimally invasive procedures inhumans or used externally or in body orifices. Further, while thedevices of the present invention are described with particular referenceto catheters/probes, this shall not be construed as limiting the devicesto these embodiments, as it is contemplated and thus within the scope ofthe illustrated devices to adapt the devices described herein so as tobe in the form of any type of minimally invasive or non-invasive deviceand sized for use for a medical procedure involving any body organ orstructure (e.g. using syringes, sheaths, wires, forceps, biopsyinstruments, clamps, retractors, micro-electronic motors (MEMS), etc.).

Further, while certain devices, systems and methods are described hereinwith particular reference to pericardial access devices, systems, andmethods, this shall not be construed as limiting, as it is contemplatedto adapt the devices, systems and methods described herein so as to beused in any of a number of procedures, including, but not limited to:various cardiovascular procedures; general micro-surgery; biopsy, drugand device delivery; vascular procedures; urology; thoracic procedures;otorhinolaryngology (ear, nose and throat); orthopedic procedures;neurosurgery; gynecologic procedures; gastroenterologic and generalprocedures; colon and rectal procedures; pericardiocentesis;thoracentesis; ascites tap; ventricular lead placements; and electricaland electro-mechanical mapping of the heart. As such, it is contemplatedthat the specific design parameters, (such as length of the distal endhaving parallel imaging and needle/instrument channels) and othercharacteristics set forth hereinafter, and methods in relation theretocan be modified to provide appropriate dimensions and geometries asrequired to perform such other techniques. For example, the length anddiameter of the device as herein described is adapted to suit theparticular conditions for a given procedure. Thus, the disclosure tofollow should be considered illustrative only and should not beconstrued as limiting in any configuration of a device as describedherein.

The device may be used to provide a three-dimensional mapping systemsolely using an incorporated ultrasound system or in connection withother imaging modalities such as optical coherence tomography, computedtomography, magnetic resonance, or videoscopy. When the device is in theform of a catheter, probe or sheath, this will allow stereotactic andremote/robotic operation of devices inserted and manipulated through thedevice. In such a system, an imaging modality (ultrasound, OCT, CT orMRI) can be used to generate a three-dimensional image on one of aplurality of two-dimensional screens. The device can interactively usethe generated images to be directed either manually or through anautomated or semi-automated process for deployment to a target areadisplayed in composite three-dimensional images from various views. Thedevice can be used in connection with an ultrasound or OCT displaysystem (B mode image or 3D image) that interfaces with the device toproduce and display the images.

By way of introduction, a fully assembled imaging device 1000 of thepresent invention is depicted in FIG. 10A-10I; (needle or syringe handle1010 and needle 1011 first shown in FIG. 10A). The present inventionincludes new embodiments of the imaging catheter of U.S. Ser. No.14/865,151 filed Mar. 24, 2015 (now allowed) and U.S. Ser. No.13/847,902 filed Mar. 20, 2013 (now U.S. Pat. No. 9,149,257) withseveral new features and alternative embodiments in its design. In thepresent invention, the transducer element may be placed close to butseparate from the introducer needle (or a syringe) so that either theone or the other may be removed and replaced at any time with anotherelement/instrument according to the needs of the surgeon. The imagingassembly lumen or channel contained within probe section 1002 (FIG. 10B)and the needle/instrument lumen or channel 1003 located above anultrasonic probe housing 1002 are placed in the center and top of thedistal end of the device respectively. The ability to change imagingassemblies at will in real time during a procedure enables higherfidelity imaging as the operating site within a body is approachedduring a procedure by a needle, syringe tool or sheath within, forexample, needle channel 1003. In one embodiment of the present inventionas shown in FIG. 1A, the image quality may be improved by placing avertical window 105 at the end of the imaging lumen or channel insteadof an angled (or tapered) window or a dome which may be used in thealternative and may expand the imaging zone to hemispheric proportions.Another important new feature is a reusable imaging transducercomprising a linear phased array (FIG. 14A) contained in a separateimaging transducer assembly probe section insertable into a probehousing and top-mounted needle guide (for example, FIG. 1A or FIG. 8A or8B that opens from the top, each transducer assembly operating at adesired ultrasound or optical coherence frequency range. The imageguided catheter/probe device of the present invention comprises anexpendable housing 102, 202, 502, 809, 909, 1009, 1109 with a proximalcable end 1006A proximal to the healthcare professional using thedevice, a distal tip 104, 204, 904, 1004 having an introducer needle,syringe or tool 1010, 1011 for insertion of the device into a patient'sbody or just the needle/syringe which is replaceable with otherinstruments, an imaging lumen or needle channel 103 that may open torelease the needle/tool/instrument. In other words, the present devicemay be used subcutaneously, in a body orifice or external with just aneedle puncture to introduce, for example, a biopsy needle or syringe.

In the image guided catheter/probe device (for example, FIG. 10A of thepresent invention), the distal housing, syringe and needle guide may bedisposable and the imaging transducer assembly (more expensive)replaceably introduced through an imaging lumen channel in sheath 1009and probe housing 1002 and may be removed and reused, separated from thedevice and cleaned if necessary. To reuse an imaging transducerassembly, for example, the front-end assembly seen in FIG. 14A, may becovered by window (for example, distal tip window 105 of FIG. 1A beingdisposable, removable and plastic or uncovered but protected within thedistal probe housing while in use and sterilized between uses. Thepresent invention is designed such that the imaging transducer assemblymay have a curved cable shape that fits into a lengthwise slot on, forexample, the left (or right) side, top or bottom, of the housing barrel,allowing the transducer assembly to slide into the imaging channel orprobe housing 1460. The present invention may also include lockingmechanisms or tabs (such as locking tab 101) to temporarily secure theimaging transducer assembly. The syringe/needle assembly has a needlechannel that is opened either via a tab 106 (FIG. 1A) or via a sleevelock 823 (FIG. 8A) to the proximal cable end 1306A of the reusablehousing 1006A, 1006B, 1006C (FIG. 10C) which may reside in disposablesheath 1009.

The reusable imaging ultrasound transducer assembly section 1006A,1006B, 1006C assembly may also be freely removed and replaced at anytime during a procedure. For example, a lower-frequency transducerassembly 1462 adapted to produce images at a lower resolution butgreater depth into the body may be used to find a target site in apatient's internal target organ. Once the target site is found, the usercan remove a lower-frequency range transducer assembly and replace itwith a higher-frequency range transducer assembly 1462 such as an OCTassembly to produce a higher-resolution image at the target site (withthree dimensions) allowing the user to obtain an improved quality imageor sequential series of images while performing a procedure.

The expendable housing, for example, housing 102, 809, 909, 1009 may bea variable outer diameter rigid plastic sheath with a diameter in therange of 1-20 French, with current preferred embodiments in the 10 to 14French range (3.3667 to 4.6667 mm diameter) for tight work or muchlarger diameter such as 20 millimeters for larger work or to carry moreimaging capability. The imaging channel 1465 (FIG. 14B) may have alarger outer diameter than that of the syringe/needle channel, forexample channel or guide 103 or 903. The probe barrel which may enter apatient subcutaneously may be any length depending on the approximatedistance of travel from a skin insertion to a target site. The imagingultrasound transducer assembly 1362 (FIG. 13) may comprise a forwardviewing phased array probe with a variable field of view depending onthe specific array. The imaging transducer assembly 1362 may comprise anultrasound or OCT transducer at the distal end (as seen in FIG. 14B)with variable frequency, variable cross-sectional diameter, and avariable number of transducer elements or optical fibers located in asteel or rigid plastic cylinder inside the expendable housing for thereusable housing with a variable outer diameter at the proximal end andnarrow diameter at the distal end. Examples of possible arrangements oftransducer elements at the tip of the transducer are depicted in U.S.application Ser. No. 13/847,902, FIGS. 5A, 5B, and 5C. The presentinvention encompasses transducer assemblies 704 with center frequencyranges in the ten to forty megahertz range (fifteen megahertz centerfrequency shown), with a current preferred range of ten to twenty-fivemegahertz for use in traveling from external skin tissue (or theexterior of the eye) to one to five centimeters beneath the skin. Wideband OCT imaging may be performed as white light imaging as well as anarrower band near infrared imaging. However, the frequency ranges mayvary depending on the particular application for which the imagingdevice is used.

The length dimensions of the probe barrel of the device are notparticularly limited and can vary depending on the ultimate use of thedevice, the insertion point, the obesity of the patient and the distanceto the target area from the insertion point (if insertion is required).The length of the device may vary depending on the application, but apreferred range is between one to four inches to be used, for example,for vascular applications, ranging up to twenty inches (ten inches forthe proximal or surgeon end and ten inches for the distal end) to beused, for example, to perform procedures on the liver. The diameter andlength of the tapered, flat or domed end near, for example, the distaltip 105 of the housing 102 can be affected by the size of an anatomicalstructure in which it is to be inserted. For example, the tapered, flator domed distal end 105 can be of greater radius, longer or more slenderfor deep abdominal structures such as the kidneys or pelvic structuressuch as the ovaries or uterus, or can be shorter and wider for deliveryof devices into more shallow structures such as a joint, muscle, theliver, or the heart. The diameter of the distal end can also be affectedby the desired size of the incision through which device 1000 isinserted and which must subsequently be closed. The diameter of thedistal end 105 of the probe housing can also be affected by the purposefor which the device is used. For example, the diameter of the distalend can be smaller for aspiration of fluids from a target site or largerif additional ports or device/medication delivery are desired.

For example, when device 1000 is in the form of a vascular sheath (notshown), the outer diameter can vary depending on the targeted bloodvessel through which the distal tip 105 is inserted. In an embodiment,device 1000 can be in the form of vascular sheaths (not shown butexemplified in priority applications and patents) used during cardiacprocedures and can be inserted through a blood vessel in the upper thighor, alternatively, can be inserted through a blood vessel in the arm. Inanother embodiment, alternative devices 1000 can be inserted byanesthetizing an area of the patient's upper thigh and inserting thedistal end 105 (if of sufficiently narrow diameter) through a bloodvessel in the upper thigh and towards the heart. In this embodiment, thedistal end 105 can have a length sufficient to traverse this pathway, adiameter small enough and material flexible enough to be inserted into ablood vessel and advanced through the blood vessel to a target site. Inan additional embodiment, the front end of the imaging transducerassembly 1362 may be housed in a flexible material that would allow thefront end of the ultrasound transducer to advance longer distancesthrough a blood vessel along with a flexible distal end of the imageguided catheter device 1000. In a further embodiment, device 1000 canhave an introducer needle 1011 integrated (not shown) therein (withoutusing a syringe), which can enable device 700 to penetrate directly intothe chest wall of a patient for direct access to the heart without theneed for access through the vascular system. A cardiocentesis may beperformed in this way using an introducer needle 1011 followed by asyringe 1011 once the heart is reached and the introducer needlereplaced with the syringe to alleviate some excess body fluid in thepericardial space.

Device 1000 can also be in the form of a sheath (not shown) used, forexample, during a laparoscopic procedure, and in such a case, the distal(patient) end 105 can generally have an outer diameter in accordancewith conventional laparoscopic sheaths and will have a length thatprovides access to the target site.

Further, the device can be used as a minimally invasive conduit from theskin surface to the target site to allow passages of catheters, guidewires (not used in the depicted embodiment 1000), and other instrumentsthrough distal tip 104 of the depicted needle guide, and the distal tip104 can be sized to allow these various instruments to be passedtherethrough. The user of the device may change the imaging transducerassembly 1462-1 through 1462-23 as needed during a procedure to obtain abetter image, and the user may also change the instrument contained inthe needle channel 103, 1003 as needed to perform the procedure.

In an exemplary embodiment described in more detail herein, device 1000can be in the form of an image guided catheter 1000 that can beintroduced through the chest, side or back to access various internalstructures using minimally invasive techniques. As such, the distal end104, 105 can have an outer diameter ranging from about 1F to 15F(wherein 1F=0.33 mm) up to about six millimeters and a length rangingfrom about 1″ to 20″. Specific lengths and diameters can be providedbased on the insertion site of the catheter/probe, the distance to thedesired target site(s), the obesity of the patient and the spacerequired for insertion of one or more interventional devices through thedistal (patient end) tip 104.

In other embodiments, device 1000 can be in the form of anyinterventional device that can be, for example, inserted through asheath (not shown) or catheter to access various internal structuresusing minimally invasive techniques. As such, the distal tip 104, 105can have an outer diameter sized so as to fit within conventionalsheaths or catheters, and a length suitable to access the desired targetsite(s) through the sheaths or catheters.

FIG. 1A depicts a view of a patient or distal end of an image guidedcatheter device assembly which may be referred to herein as a barrel (asdistinct from a larger diameter proximal end, not shown) in accordancewith one or more aspects described herein, FIG. 1A showing a replaceableintroducer needle/syringe/instrument channel/lumen having a distal tip104 visible in an imaging zone of a replaceable transducer element 1362(FIG. 13) replaceable as higher resolution is needed when the accessinstrument reaches the operating site if used subcutaneously. As shownin FIG. 1A, the ultrasound or OCT transducer or other known visionelement being the distal tip 105 of the device 1000 at the patient endhas an imaging zone desirably encompassing the tip of the introducerneedle 1011 (typically pointed) or biopsy needle or syringe (typicallyhollow) as it emerges from guide or channel 103. FIG. 1A shows anintroducer needle lumen or channel 103 of a needle guide mounted abovean ultrasound or OCT imaging lumen or channel ending at tip 105 that iscaptured by a imaging plane of an ultrasound transducer array; (seeFIGS. 9E, 9I). The removable, replaceable imaging transducer assembly1362 (not shown) may be inserted into the imaging probe barrel as willbe discussed herein in real time during a medical procedure. To reduceultrasound deflection during use of the device, as seen in FIG. 1A, theimaging system can be provided with matching layers disposed, forexample, adjacent the front face of transducer elements. Matching layerscan facilitate the matching of an impedance differential that may existbetween the high impedance transducer elements and a low impedancepatient. The structure of matching layers can generally be in accordancewith conventional matching layers and generally can include a matchinglayer front face and a matching layer rear face, and can optionallyinclude a pocket with matching material that can reduce ultrasounddeflection. Suitable matching layer materials can include, for example,plastic materials such as polysulfone or REXOLITE® (a thermoset materialproduced by crosslinking polystyrene with divinyl benzene, availablefrom C-LEC Plastics, Inc., Beverly, N.J.).

The imaging system may further include a backing layer (not shown) inaccordance with conventional backing layers. The backing layers cangenerally be coupled to the rear face of the transducers 1462-1 through1462-23 (FIGS. 14A and 14B) and function to attenuate acoustic energythat emerges from the rear face of the transducer elements. Generally,such backing layers can have a front face and a rear face, and can befabricated of acoustic damping material that possesses high acousticlosses.

Transducers can be of a size and composition in accordance withconventional transducers. For example, in some embodiments, thetransducer elements can comprise natural piezoelectric materials such asquartz, topaz, or tourmaline group minerals or can comprise man-madematerials such as PZT ceramics or piezoelectric polymers such asPolyvinylidene fluoride (PVDF). In other embodiments and for highresolution and all-optic ultrasound transducer is useful. Transducerelements can also be of any suitable size, with such size being limitedby the desired size of the housings used and the use which is being madeof the ultrasound, i.e., for imaging or therapeutic purposes.

In currently preferred embodiments, as many as 20-96 channels(twenty-three by way of example) may be provided from the ultrasoundtransducer array to the display output device through the ultrasoundtransducer and cable assembly. However, further embodiments of thetransducer assembly may contain anywhere from one to 2000 ultrasoundimaging channels, with a greater number of parallel channels possible asultrasound imaging technology progresses toward smaller elements suchas, for example, fiber optics. Moreover, known contrast agents may beintroduced through a hollow needle or sheath lumen through a bloodvessel and may be known to adhere to, for example, human muscle tissueor a heart valve or other organ of interest to improve echogenicity justas the needle, sheath or a tool may have an echogenic surface such as aspirally wrapped wire round the needle or syringe.

FIG. 1B depicts a top view of a needle guide 103 of FIG. 1A to show howguides 121 and 122 guide a needle or tool into a needle channel and canrest on needle buttons 107A and 108A of one side of the needle guide 103and also rest on needle buttons 108A and 108B of the other side of theneedle guide. FIG. 1A disposable housing and needle guide is operated bytab 106 to rotate one half of a needle guide to match with the otherhalf.

FIG. 1C depicts an open front view of the needle guide 103. A needle(syringe or tool) may be moved out of the needle guide 103 due toopening guides 121 and 122. Button tabs 107A and 107B along with buttontabs 108A and 108B help extricate the needle from the needle guide 103from above. Such an open needle guide precludes the collection ofmaterial which may adhere to a needle or syringe or other bodilymaterial at the needle guide end 104 when the needle is removed througha closed needle guide.

FIGS. 2A and 2B depict different cross-sectional views of the patient ordistal end of the embodiment of FIG. 1A where tab 106 for closing theneedle channel is now referenced as tab 206 for opening the needlechannel 203 of an imaging device in accordance with one or more aspectsdescribed herein. When tab 206 is manipulated in a clockwise direction,the needle channel is closed around a needle/syringe/tool not shown oropened to allow vertical removal. FIG. 2B shows additional button tabs209, 210 which may be used or not used in a given embodiment to furtherserve to support a needle/syringe/tool in needle channel button tabs;(see FIGS. 1B and 1C). Needle channel tip 204 may be tapered and mayreceive and permit a tapered tip hollow needle (possibly of a syringe)to exit the needle guide at tip 204. Sensor channel tip 205 may indicatethe location of an ultrasound sensor not seen which may be directedforward and provide forward-imaging of a needle/syringe/tool in theneedle channel 203 as it extends into a forward imaging zone of atransducer array (such as array 1362 of FIG. 13). In either figure, arear tab 101, 201 may lock a sensor and cable section assembly in placewithin the body 202 comprising a sensor channel (transducer assembly andcabling). Needle 1010 and sensor and cable assembly 1006 are first seenin FIG. 10 locked in place by tab 1001.

FIG. 3A provides an enlarged front-end view of the tab 106 now seen astab 306A which may move between positions 309 and 310 to open or closethe needle channel. In FIG. 3A, the needle channel tip 304A is shownclosed.

In FIG. 3B, the needle channel tip 304B is shown open. Similarly, afirst part of the needle channel 321A is shown closed in FIG. 3A and thesame part of the needle channel 321B is shown open in FIG. 3B. Sensorchannel 302 of either of FIGS. 3A and 3B carries the sensor and cable tothe sensor channel tip 305. A second part of the needle channel 322A or322B remain stationary where line 320 represents the line along whichthe needle channel opens. Section A-A extends from the top of the needlechannel through the sensor body 302.

FIGS. 4A and 4B depict details of the opening and closing of a needlechannel using circularly moveable tab 106 where FIG. 4A represents aclosed needle channel and FIG. 4B represents an open needle channel, forexample, where partial circular sections connected to tab 106 compriseline 420 along which the needle channel opens. FIG. 4A comprises closedneedle channel tip 404A, the first part 421A of the closed needlechannel, the second part 422A of the closed needle channel, and thesensor channel tip 405 of the ultrasound sensor channel. Referring toFIG. 4B, sensor channel tip 405 is in the center. Surrounding thiscenter 405 are open needle channel tip 404B, open second part 422B ofthe needle channel and open first part 421B of the needle channel.Section C-C is taken just of the probe housing as seen in FIG. 1A.

FIGS. 5A and 5B depict in rear perspective view a closed needle channel504A (FIG. 5A), button tabs 507, 508, and closed needle entry 503A (FIG.5A) leading to distal closed tip 504A (FIG. 5A) of the needle channelsensor channel tip 505 (seen in both FIGS. 5A and 5B). The sensor body502 in both FIGS. 5A and 5B has a flexible locking tab 501 for allowinga sensor probe and cable assembly to be placed within the housing perFIG. 10. Closing tab 506A in FIG. 5A shows a close position for theneedle guide while closing tab 506B in FIG. 5B shows an open positionfor the needle guide as per open needle guide 503B. Distal tip 504A isshown closed in FIG. 5A and open tip 504B is shown in FIG. 5B. Circle Dshows the difference between closed needle guide 503A (FIG. 5A) and openneedle guide 503B (FIG. 5B) where opening and closing uses tabs 506A(closed) and the same tab 506B in an open position.

FIGS. 6A through 12I show an embodiment similar to the previouslydiscussed embodiment whereby a sleeve lock is used to lock two halves ofa needle channel of a needle guide together around an inserted tool:needle, syringe or other tool. Normally, the needle guide is open butmay be closed by a sleeve lock as discussed herein.

FIGS. 6A and 6B depict front perspective views of the line 620 alongwhich the needle channel 603 opens along with a portion of the sensorhousing or body 602. Referring to FIG. 6A, needle channel 603A is in aclosed position, the first part of the needle channel 621A is closed asis the second part (for example, half) of the needle channel 622A.Referring now to FIG. 6B, the needle guide is in an open position 603Band the first and second parts 621B and 622B (for example, halves) ofthe needle channel are opened to their normally open position.

Thus far, we have discussed how a tab 106 may open and close a needlechannel. In FIGS. 7A through 8H and in FIG. 9A an alternative to a tabclosure is shown that comprises a sliding groove 724 moved by a surgeonvia a circular or partially circular tab or sleeve lock 723 withunnumbered finger grips seen as rounded gripping ridges on the sides ofthe sleeve lock 723.

FIG. 7A shows sensor housing channel 702 and the needle channel 703 in aclosed position where the circular tab or sleeve lock 723 and groove725A have been slid forward to clasp the two halves of a needle guide703 together. The groove may have parallel sides shown or have V-shapedclasping sides (not shown). The parallel sides 721 and 722 (FIG. 7B) ofgroove 724 may have a corresponding quarter-circular portion 725A whichgathers the two sides 721, 722 of the needle guide together, and thegroove 724 holds the needle guide together. A retaining spring tab 712retains the sleeve lock so as to close the needle channel 703. Anycircular arc 725A may mate with a similar arc to close the normally openneedle channel 703 in groove 704. Another example is an approximatelyforty-five degree angle on each of the groove 724 as 725A and the halvesof the needle guide 703.

In FIG. 7B, it may be seen that a matching quarter-circular portion 725Bmatches portion 725A and so, when they meet as the tab 723 is closed,the two sides 721, 722 of the needle guide 703 are caused to collapseand be held by together by the groove 724 via sleeve lock 723 as seen inFIG. 7A. As already discussed, a quarter circle is shown but may beanother arc of a circle or a cut at, for example, a forty-five degreeangle.

FIG. 8A depicts a top down view of the groove closure of FIGS. 7A and7B. As already seen, sensor housing 809 has a locking tab 801 forlinking with a sensor and cable assembly seen in FIG. 10. Needle guide803 is seen held closed in a groove and is so held in a closed positionas long as the groove grips the halves of the needle guide 803 together.Flexible retaining tab 812 holds sleeve lock 823 closed also closingneedle channel 803.

FIG. 8B provides a side cross-sectional view of the sensor and needleguide assembly shown in top view in FIG. 8A. Sensor 802 has a flexiblelocking tab 801 for linking to an internal transducer and cable assemblyper FIG. 10 as seen in FIG. 8A in top view. Needle guide 803 is shownclosed with button tabs 807 and 808 for supporting a needle, syringe orother tool. A flexible retaining tab 813 prevents a sleeve lock 823 fromopening any further than its raised edge.

FIG. 8C depicts an expanded view of the closing groove mechanism (DetailB) for closing the needle guide first and second parts 821 and 822 alongline 820 via quarter-circular groove portions 825A and 825B (or othercircular arcs or forty-five degree cuts) so that sleeve lock 823 in aforward position closes the normally open needle guide halves within thedepicted groove 824.

FIG. 8D shows a side view similar to the side cross-sectional view ofFIG. 8B. The sensor channel 802 is seen at the distal end and the tab801 at the proximal end. The finger grip 823 is shown extended so as toforce the needle channel 803 closed with button tabs 807 and 808.

FIG. 8E is a front perspective view of the sensor housing of FIG. 8D. Anultrasound sensor channel 802 is located below the needle channelindicated by button tabs 807 and 808 and needle guide opening 803. Theneedle channel 803 is closed by sleeve lock 823 and retained in a closedposition by flexible retaining tab 812, the sleeve lock 823 havingfinger grips as seen and a groove (not visible) which holds the halvesof the needle guide 803 together. Also shown are a disposable plasticsheath 809 and flexible locking tab 801 for locking together with asensor and cable assembly seen in FIG. 10. Circle D will be described inFIG. 8F.

FIG. 8F provides an expanded view (Detail D) of the sleeve lock 823showing needle guide halves 821, 822 held together in a groove 824facilitated by quarter-circular section 825A (or other arcs of a circlemay be used or a straight cut of the groove 824 and needle guide halvessuch as at a forty-five degree angle.

FIG. 8G shows a rear perspective view of the needle guide and sensorhousing with flexible locking tab 801, needle guide 803, button tabs807, 808, sensor housing 803, quarter-circular section 825A of agripping groove of sleeve lock 823 held in closed position by flexibleretaining tab 812 and disposable plastic sheath 809. Circle C will bedescribed with reference to FIG. 8H.

FIG. 8H provides a rear expanded perspective view of the closure ofneedle guide 803 (Detail C) having flexible halves 821 and 822 within agroove 824 of sleeve lock 823 showing a quarter-circular section 825Afor matching with a needle guide quarter-circular section 825 alongclosure line 820. As explained above, other arcuate cuts of groove 824may match with arcuate cuts of needle guide halves or a line cut at anangle of approximately forty-five degrees may be applied to closenormally open halves 821 and 822

FIG. 8I provides a cross-section of the disposable plastic sheathportion including sheath 809, the needle channel distal tip 804 and thesensor channel tip 805 which may comprise a window for an internalultrasound transducer assembly (not shown).

FIGS. 9A through 9I provide views of a combination assembly of thesensor housing and needle guide section (distal or patient end) with thesensor and cabling section (proximal end) using the groove needle guidelocking mechanism or sleeve lock 923 as discussed above. Referring toFIGS. 9E and 9I, for example, an imaging plane of a transducer array isaligned with a needle/syringe delivery port so that the imaging planecaptures images of the tool as it emerges into the imaging plane and asurgeon need not optimize the delivery of the tool to be seen byreflected ultrasound.

FIG. 9A provides a top view of the combination assembly comprising fromleft to right sensor channel tip 905 with a needle guide tip directlyabove but not easily discernable. Sensor channel or probe housing 902holds, for example, a probe comprising a linear phased array with eachelement connected to leads of a cable (not seen) until the cable exitsat right as cable 906A. Flexible needle guide 903 in flexible halves isshown closed within a groove of circle B. Gripping tab or sleeve lock923 that may slide back is shown closed and retained by retaining tab912 so that a groove closes needle guide 903 having flexible halves thatclose together around a needle, syringe or other tool. Next to the rightis disposable sheath 909 and a cable joining section 906B of a probe,probe housing and cable assembly locked together as will be discussedwith reference to FIG. 9B.

FIG. 9B is a cross-section along line A-A of FIG. 9A so as to see theinternal components of the combination assembly. A right-sidecross-section of the assembly comprises from right, cable 906A whichmerges with cable joining section 906B and the individual piezoelectricelement leads pass through sections 906B and 906C (a probe section) to,for example, a linear phased array of elements facing forward at sensortip 905. A flexible locking tab 901 locks needle guide section 902, 903,904, 907, 908, along with cable section disposable housing 909 to theinternal cable and sensor sections 906A, 906B and 906C.

FIG. 9C is a further exploded top view (Detail B) of the needle guidelocking mechanism comprising along closing line 920 a firstquarter-circular groove section 925A and an opposite quarter-circulargrove section 925B of groove 924 of sleeve lock 923 which close aroundneedle guide halves 921 and 922 to close the needle guide 903. Asalready discussed, a quarter-circle cut is one of many cuts of thegroove 924 and of the halves of the normally open flexible needle guide903.

FIG. 9D is a complete assembly side view comprising from left to right asensor tip 905, a sensor probe housing 902, needle guide button tabs 907and 908 and needle guide 903. The sleeve lock 923 is seen in a closedposition so that normally open flexible needle guide 903 would beclosed. Disposable plastic sheath 909 is seen next with flexible lockingtab 901 holding sensor and cable assembly 906A and 906B in place, mostlyinternally within the housings/sheaths 902 and 909.

FIG. 9E provides a front perspective view of the entire assembly.Starting from left is seen the sensor housing tip 905, the probe housing902, needle guide button tabs 907, 908, the flexible, normally openneedle channel 903 with sleeve lock 923 having quarter-circular section925A for locking the needle guide 903 in a groove of sleeve lock 923 ina closed position (Circle D discussed in FIG. 9F) held by flexibleretaining tab 912, disposable plastic sheath section 909 (coveringcable, not visible and, for example, containing an accelerometer and/orat least one gyroscope for alignment of images with gravity) andultrasound sensor and cable sections 906B and cable 906A may be seen.When sleeve lock 923 is moved to the rear opening the normally openneedle channel 903 via the sleeve lock 923, the sleeve lock 923 isretained by a flexible retaining tab on the bottom of sheath 909. Aforward-directed linear phased array may be located just behind sensortip 905 as will be discussed later herein. An approximatelytwo-dimensional ultrasound imaging plane 919 is shown to be orientedperpendicular to the face of the ultrasound array to the center of theneedle port delivery port portion of the sheath; (see also FIG. 9I).This ensures that during a procedure the needle or other tool emergingfrom the needle guide 903 at its distal port is automatically visible inthe ultrasound image without the physician needing to adjust therelative orientation of a sheath or ultrasound probe.

FIG. 9F provides a front perspective view of the needle guide lockingmechanism in a closed position along line 920 (Detail D). Sleeve lock923 locks normally open, flexible needle guide halves 921 and 922together in a groove 924 having a quarter-circular section 925A and arear groove face 926A and is retained in closed position by flexibleretaining tab 912 (FIG. 9E). As already discussed, other arcuate cuts ofthe groove 924 and halves 921, 922 will also close the needle guidechannel as will an approximately forty-five degree angle cut.

FIG. 9G provides a rear perspective view of the combination assemblyfrom left to right comprising the sensor housing tip 905, the probehousing 902, needle guide button tabs 907, 908, the normally open needlechannel 903 with sleeve lock 923 having quarter-circular section 925Afor locking the needle guide 903 (in circle C) in a groove of sleevelock 923, disposable plastic sheath section 909 (covering cable) andultrasound sensor and cable sections 906B and cable 906A may be seenalong with flexible locking tab 901 for holding the outer housingtogether with the probe and cable assembly inner housing. Aforward-directed linear phased array may be located just behind sensortip 905 as will be discussed herein.

FIG. 9H is an exploded view of Detail C where needle guide halves 921,922 of needle guide 903 are held together by a groove 924 of sleeve lock923.

FIG. 9I is very similar to FIG. 8I and shows a cross-section of thedisposable plastic sheath portion 909, the needle channel tip and thesensor channel tip 905, the needle channel tip being the end portion ofthe needle guide 903. The exact orientation of the ultrasound imageplane 919 is shown to intersect the center of the imaging array andneedle delivery port, thereby ensuring that the needle or other toolbeing delivered will be visible in a processed ultrasound image (notshown) without the physician having to adjust the relative position ofthe sheath or ultrasound probe.

FIGS. 10A through 10I depict several views of the above-described needleguide embodiment and probe and cable assembly also including anexemplary needle having a handle 1010 and a tip 1011. The needle 1011and handle 1010 are shown in the needle channel 1003 having flexiblehalves. The needle 1010, 1011 may be a biopsy needle and be hollow forcollecting tissue at a site of interest or a syringe for removing fluids(for example, during a cardiocentesis) located by forward-imaging of atransducer array located behind sensor tip 1005. Flexible retainer tab1012 retains sleeve lock 1023 in a closed position and normally openneedle guide 1003 is locked closed.

FIG. 10A shows section A-A seen in FIG. 10B. FIG. 10A from left to rightincludes but is not limited to showing needle tip 1011, closed butnormally open needle guide 1003, sleeve lock 1023, needle handle 1010,circle B for explaining the locking mechanism, disposable plastic sheathsection 1009; letter A where the locking tab 1001 would be located onthe underside and is not visible, locking the entire assembly includingcable narrowing section 1006B and cable section 1006A. Needle handle1010 may comprise a syringe.

FIG. 10B shows section A-A comprising from left to right a needle tip1011, button tabs 1007 and 1008 which assist in lifting needle 1011 outof the needle channel 1003, sensor tip 1005, probe and cable housing1006C, piezoelectric element leads 1002, needle handle 1010, flexiblelocking tab 1001 in the vicinity of A of FIG. 10A, cable narrowingsection 1006B and cable section 1006A.

FIG. 10C provides an expanded view of detail B (circle B of FIG. 10A)showing the normally open, flexible needle channel halves 1021, 1022 ina locked and closed position in groove 1024 having been guided intogroove 1024 by quarter-circular edges 1025A, 1025B of the distal end ofgroove 1024 (also other arcs or linear cuts may be used). FIG. 10C alsoshows needle handle 1010 and a top viewable portion of sleeve lock 1023.

FIG. 10D is a side view of a complete assembly including both a probeand cable housing portion 1005, 1002, 1009, a locking sleeve 1023 heldin a closed position by retaining tab 1012, a needle 1011 and handle1010 held in needle channel 1003 by button tabs 1007, 1008 and adisposable sheath 1009 having a flexible retaining tab 1001 for securing(or releasing) a cable and probe section 1006A, 1006B, 1006C. Retainingtab 1013 stops sleeve lock 1023 from moving rearwards along sheath 1009but is used during assembly as will be described herein for installingsleeve lock 1023.

FIG. 10E provides a front perspective view of a complete assembly asseen in FIG. 10D comprising four components, a needle 1011 and needlehandle 1010, the needle residing in a needle channel 1003 of a needleguide, the needle 1011 supported by button tabs 1007 and 1008 of theneedle guide portion of a probe and cable housing comprising the needleguide, a distal probe tip window 1005, a probe housing 1002 and adisposable sheath 1009 having a flexible locking tab 1001 for locking,for example, a probe containing a linear phased transducer array locatedbehind the window 1005, and element leads to a cable exiting the sheath1009 via cable narrowing section 1006B while cable 1006A leads to aprocessor and display (not shown) and the sleeve lock 1023 which is sliddown sheath 1009 and over retaining tab 1012 to close needle channel1003 over needle 1011. Circle D will be discussed with reference to FIG.10F.

FIG. 10F provides an expanded view of detail D (circle D of FIG. 10E)showing the normally open, flexible needle channel halves 1021, 1022 ina locked position in groove 1024 having been guided into groove 1024 byquarter-circular edges 1025A, 1025B (not visible) of the distal end ofgroove 1024 joining the two halves 1021, 1022 of needle channel 1003. (Adiscussion of alternative edges will not be discussed again.) FIG. 10Falso shows needle handle 1010 and a top viewable portion of lockingsleeve 1023.

FIG. 10G provides a rear perspective view of a complete assembly as seenin FIG. 10D comprising four components, a needle 1011 and needle handle1010; the needle 1011 residing in a needle channel 1003 of a needleguide, the needle 1011 supported by button tabs 1007 and 1008 of theneedle guide portion of a probe and cable housing comprising the needleguide, a distal probe tip window 1005, a probe housing 1002 and adisposable sheath 1009 having a flexible locking tab 1001 for locking,for example, a probe containing a linear phased transducer array (notshown) located behind the window 1005, and element leads to a cableexiting the sheath 1009 via cable narrowing section 1006B while cable1006A leads to a processor and display (not shown) and the sleeve lock1023 which is slid down sheath 1009 during assembly and over retainingtab 1012 to close needle channel 1003 over needle 1011. As alreadydiscussed, an accelerometer and/or at least one gyroscope may be locatedin sheath 1009 for maintaining an image on a display (not shown) inalignment with the gravitational field of the earth. Circle C will bediscussed with reference to FIG. 10H.

FIG. 10H provides an expanded view of detail C (circle C of FIG. 10G)showing the normally open needle channel halves 1021, 1022 in a locked,closed position in groove 1024 having been guided into groove 1024 byquarter-circular edges 1025A, 1025B (not visible) of the distal end ofgroove 1024 joining the two halves 1021, 1022 of needle channel 1003 toform a closed needle channel. FIG. 10H also shows needle handle 1010 anda top viewable portion of locking sleeve 1023.

FIG. 10I is very similar to FIGS. 81 and 9I but differs in showingneedle tip 1011 emerging from needle guide 1003 and shows across-section of the disposable sheath portion 1009, the needle channeltip 1004 and the sensor channel tip 1005 with the end portion of theneedle guide 1003.

FIG. 11A provides a top view of a complete assembly of an image guidedcatheter or probe 1100 as seen also in FIG. 10E with sleeve lock 1123open comprising four components, a needle 1111 and needle handle 1110,the needle still residing in a needle channel 1103 of a needle guide,the needle 1111 supported by button tabs (not visible) of the needleguide portion of a probe and cable housing comprising the needle guide,a distal probe tip window 1105, a probe housing 1102 and a disposablesheath 1109 having a flexible locking tab (not visible) for locking, forexample, a probe containing a linear phased transducer array locatedbehind the window 1105, and element leads to a cable exiting the sheath1109 via cable narrowing section 1106B while cable 1106A leads to aprocessor and display (not shown) and the sleeve lock 1123 which is sliddown sheath 1109 and over retaining tab (not visible) to close needlechannel 1103 over needle 1111 via groove 1124. Circle B will bediscussed with reference to FIG. 11C. Cross-section A-A will bediscussed with reference to FIG. 11B.

FIG. 11B provides a cross-section view of a complete assembly along A-Aof FIG. 11A and comprises four components, a needle 1111 and needlehandle 1110, the needle 1111 residing in a needle channel 1103 of aneedle guide, the needle 1111 supported by button tabs 1107, 1108 of theneedle guide portion of a probe and cable housing comprising the needleguide located at the top, a distal probe tip window 1105, a probehousing 1102 and a disposable sheath 1109 having a flexible locking tab1101 for locking, for example, a probe containing a linear phasedtransducer array located behind the window 1105 seen as section 1106C,and element leads (not shown) to a cable section 1106A exiting thesheath 1109 via cable narrowing section 1106B while cable 1106A leads toa processor and display (not shown) and the sleeve lock 1123 which isslid down sheath 1109 and over retaining tab 1113 to close needlechannel 1103 over needle 1111 via groove 1124. The needle channel 1103is normally open and sheath 1123 has not been moved toward the distaltip 1105 to close the normally open needle channel 1103.

FIG. 11C provides an expanded view of Detail B of FIG. 11A showing theneedle channel open and comprises the flexible needle channel halves1121, 1122 in a normally open, unlocked position outside groove 1124having been released from groove 1124 and quarter-circular edges 1125A,1125B of the distal end of groove 1124 releasing the normally open twohalves 1121, 1122 of needle channel 1003 to their open state to exposeto view needle 1110 with its handle 1111 also visible. FIG. 11C alsoshows needle handle 1111 and a top viewable portion of locking sleeve1123.

FIG. 11D provides a side view of the complete assembly of four partswith the needle channel 1103 open but the needle 1111 and needle handle1110 still residing in the open needle channel 1103. Locking sheath 1123has been moved toward the proximal end to be stopped by retaining tab1113. From left to right, imaging window 1105 of probe housing 1102 hasmounted thereon a needle guide comprising button tabs 1107, 1108supporting needle 1111 in open needle channel 1103. At the end of needlechannel 1103 is seen a quarter-circular edge of the channel which mateswith quarter-circular edge 1125A of groove of open sheath/sleeve 1123when closed but, when open, sleeve lock 1123 rests against retaining tab1113 and surrounds sheath 1109. Locking tab 1101 locks in probe andcable assembly comprising a cable narrowing section 1106B leading tocable 1106A.

FIG. 11E is a front perspective view of a complete assembly with theneedle channel 1103 open and the needle 1111 and needle handle 1110 areexposed and are supported on button tabs 1107 and 1108 of the normallyopen needle guide. From left, the probe housing tip or window 1105 isseen on probe housing 1102 while sleeve lock 1123 is shown open (movedproximally) on disposable sheath 1109. Flexible locking tab 1101 locksprobe and cable section within comprising visible cable narrowingsection 1106B and cable 1106A. Circle D will be described with referenceto FIG. 11F. Needle handle 1110 may comprise a syringe having twocylindrical sections.

FIG. 11F is an expanded view of detail D of FIG. 11E showing thenormally open needle channel halves 1121, 1122 open exposing to viewneedle 1111 and needle handle 1110 and comprises the needle channelhalves 1121, 1122 in an open, unlocked position outside groove 1124having been released from groove 1124 and quarter-circular edges 1125A,1125B of the distal end of groove 1124 releasing the two halves 1121,1122 of needle channel 1103 to expose to view needle 1111 with itshandle 1110 (which may comprise a syringe) also visible. FIG. 11F alsoshows needle handle 1110 and a top viewable portion of locking sleeve1123.

FIG. 11G is a rear perspective view of the complete assembly with thenormally open, flexible needle channel 1103 open and the needle 1111 andneedle handle 1110 are exposed and are supported on button tabs 1107 and1108 of the open needle guide. From left, the probe housing tip orwindow 1105 is seen on probe housing 1102 while sleeve lock 1123 isshown open (slid proximally) on disposable sheath 1109. Flexible lockingtab 1101 locks probe and cable section within, the section comprisingvisible cable narrowing section 1106B and cable 1106A. Circle C will bedescribed with reference to FIG. 11H. Needle handle 1110 may comprise asyringe having two cylindrical sections, one for holding fluid and apull handle for withdrawn fluid through a hollow needle 1111.

FIG. 11H is an expanded view of detail C of FIG. 11G showing the needlechannel halves 1121, 1122 open exposing to view needle 1111 and needlehandle 1110 and comprises the normally open, flexible needle channelhalves 1121, 1122 in an open, unlocked position outside groove 1124having been having been released from groove 1124 and quarter-circularedges 1125A, 1125B of the distal end of groove 1124 releasing thenormally open two halves 1121, 1122 of needle channel 1103 to expose toview needle 1111 with its handle 1110 (which may comprise a syringe)also visible. FIG. 11H also shows needle handle 1110 and a top viewableportion of locking sleeve 1123.

FIG. 11I is a top perspective expanded cross-sectional view showing openneedle channel 1103 comprising normally open needle channel halves 1121and 1122 in an open position. Needle 1111 has handle 1110 shown stillinside the open needle channel 1103 comprising halves 1121 and 1122 alsoopen. FIG. 11I further shows cross-section 1109 of disposable sheath1109 and the probe window or distal probe housing end 1105.

FIGS. 12A through 12I are identical to FIGS. 11A through 11I but for themovement of needle 1211 and handle 1210 vertically out of the needlechannel 1203 and will not be described in any detail to avoidredundancy. However, FIG. 12I will be briefly explained as it shows theneedle 1111 and handle 1110 removed from the open needle channelvertically.

FIG. 12I shows needle handle 1210 and needle 1211 removed vertically andoutside the open needle channel comprising open needle channel halves1221 and 1222. Probe distal end 1205 is seen as is the sheath section1209 in cross-section.

FIGS. 13 through 17B provide an overview of the insertable probe, cableand linear phased array transducer assembly 1006A, 1006B, 1106C, that islocked by a flexible locking tabs 101, 201, 501, 801, 901, 1001, forexample, inside disposable sheaths 102, 202, 502, 909, 1009, forexample.

FIG. 13 provides a side view at its center of a plurality ultrasonicelements (not visible) of a transducer probe according to the presentinvention which may have a protective sheath (for example, sheath orprobe housing 702 of FIG. 7) disposed between the probe 1361 locatedtoward the distal tip 1360. All distances if any are shown areapproximate and may be changed for different applications such asreaching the heart pericardial sac (also known as the pericardial space)versus reaching a melanoma close to the skin or a kidney with ananterior approach with optimized resolution and are shown inmillimeters. A convention used in the brief and detailed description isthat a reference numeral YXX may be used wherein the Y provides theFigure number where an element first appears and the XX (which may beany two-digit number) may represent the reference numeral of the element(used consistently for a similar component), for example, transducerarray 1362 comprises Y for FIG. 13 and XX for numeral 62 whichrepresents the transducer array while element 1310A represents thecylindrical housing 1310A shown in FIG. 13 held within disposablesheath, for example, 1109 by a surgeon (not shown in this figureseries). To the left of FIG. 13, is seen a cross-section of a plane ofhousing 1310A including both the probe 1361 and the cylindrical housing1310A. At the right of FIG. 13 is shown a cross-section 1340 intended toshow the radially placed elements of the outer cylindrical housing1310A, cable transition portion 1206B, the strain relief feature and thecable 1206A including, for example, the twenty-three leads to thetransducer linear phased array, shown by way of example, which in turnleads to a display processor and display. Views 1361, 1362, 1316 areshown enlarged as FIGS. 14A (end view) and 14B (cross-sectional topview) of exemplary linear phased array elements 1462-1 through 1462-23.

FIG. 14A shows a first exemplary embodiment of a front view of anexemplary ultrasound linear phased array having, for example,twenty-three linear elements 1462-1 through 1462-23 of, for example, 0.1millimeters pitch (approximately one lambda wavelength of the centerfrequency of fifteen megahertz) making a total array 1362, 1462 of about2.3 millimeters by 2.3 millimeters for a center frequency ofapproximately fifteen megahertz. The center frequency for a probe linearphased array may be selected within a range of ten to forty megahertz,and each piezoelectric element may have a pitch of between 0.85 to 1.15times the wavelength of the selected center frequency. A moreconventional pitch or 0.5 to 0.6λ may also be used but will increase thenumber of cable leads to the array and may impact subcutaneous use dueto need for a larger diameter probe. Not shown in FIG. 14A or distal tip1360 of FIG. 13 is that the linear phased array may be protected withina dome, flat window, no window, or tapered window of the housingincluding the needle guide. On the other hand, a window at distal tip105 of a probe housing per FIG. 1A, for example, may comprise a dome orwindow protecting the transducer array. A probe shaft cylindricalhousing 1410A (FIG. 14B) is seen that may have a circularcross-sectional shape that is approximately four millimeters in diameteras seen in FIG. 13. Not shown, the probe shaft cylindrical housing 1410Amay contain electrical signal leads to the linear phased transducerarray 1362 for transmitted and reflected ultrasound signals and anaccelerometer and/or at least one gyroscope having leads which producesignals which when processed may be used to align any image on a display(not shown) with the gravitational field of the earth. One transducerarray may be replaced with another transducer array having a differentcenter frequency and similar one lambda or a conventional half lambdapitch (but more linear elements) and still fit within the outer probehousing diameter, for example, four millimeters. The array 1362 maycomprise individual linear phased array transducer elements comprising aone by twenty-three linear array shown as elements individually numbered1462-1 through 1462-23. More elements would be needed for a conventionalarray of linear elements at one half lambda pitch. The white areabetween the linear phased transducer array 1362 and the housing 1361 isun-numbered and comprises a potting material 1464 seen best in top-downcut-away view FIG. 14B. As described above these array elements 1462-1through 1462-23 for different center frequency may be contained within aprobe insertable into a disposable outer housing, FIGS. 1 through 12I sothat transducer arrays may be exchanged for different applications ofthe probe.

FIG. 14B shows a top sectional 1460 comprising the distal tip and, inparticular, comprises from left to right a cross-hatched probe shafthousing 1410A, an array potting material 1464 to firmly grasp the linearphased array elements 1462-1 through 1462-23 (FIG. 14A). Below thesection 1460, there is seen at the center of the probe shaft housing1410A, an aperture for conducting an electrical signal cable 1465,narrowing the signal cable 1465 from the diameter of cable channels topiezoelectric elements 1462, the leads carrying signals to/from thelinear phased array elements 1462-1 through 1462-23 via the arraybacking 1463. The aperture is preferably walled as shown and extends theentire length of the probe shaft housing, carrying the electrical cable1465.

FIG. 15A is a blow-up of the left side cross-section of FIG. 13. Thereis a section labeled 1316 intended to represent a thicker portion of thehollow cylindrical housing 1310A of FIG. 13. A pair of broken lines,perpendicular to one another signifies the center of the cylindricalhousing 1310A. Similarly, a pair of solid lines perpendicular to oneanother signifies the center of the probe shaft housing in circle A suchthat the distance between the two centers may be approximately sixmillimeters and the diameter (shown as a single line and arrow tip) ofthe cylindrical housing 1310A may be approximately 17.5 millimeters(within a range of, for example, twelve to twenty-five millimeters).

FIG. 15B is a blow-up of detail A of FIG. 15A showing the relationshipbetween the linear phased transducer array 1462, its probe shaft 1461which may comprise potting material 1464 and the outer wall 1416 of thecylindrical housing 1310A. The partial circular line is intended to showthat wall 1416 only represents a portion of cylindrical housing 1310Aand should not be considered a part of the image guided probe which maybe reusable and removable from the outer sheaths depicted in Figuresdescribed above.

FIG. 16 provides either a top-down view or a bottom-up view of the imageguided probe at the center of FIG. 13 (without showing details of anysheath for protecting the probe so that the probe housing is reusable).The view shows the probe 1350's distal end 1360 where would be locatedthe linear phased transducer array 1462 of the present invention. Thecenter section is the cylindrical housing 1310A that is covered by adisposable sheath that may be grasped and utilized by a surgeon. Thesection transition feature 1315 provides a side view of an exampletransition between the probe's cylindrical cable housing 1310A and thecable strain relief feature 1306B which provides the exit of cable 1306Afrom the imaging probe for image processing and display.

FIG. 17A is a left front perspective view of an image guided probecomprising distal probe end 1360, probe shaft 1350, cylindrical housing1310A, transition feature 1315, flexible cable section 1306B and cable1306A from left to right.

FIG. 17B is a right rear perspective view of an image guided probeshowing the same components in the same order as is seen in FIG. 17Afrom upper left to lower right.

Assembly of a device 1000 will now be described with reference to FIGS.10A and 10B starting with section 1009, 1002, 1005. The sleeve lock 1023is introduced from the right (proximal end or surgeon end) by passingsleeve lock 1023 over sheath 1009 via flexible locking tab 1001. Thesleeve lock is moved toward the distal end and passes over flexibleretaining tab 1013 where it is locked between an open and a closed(distal) position. With the sleeve lock proximate to tab 1013, thenormally open needle channel is open so that needle 1011 and handle 1010may simply be lain vertically unto button tabs 1007 and 1008 within thechannel. Then, the sleeve lock 1023 may be moved forward over flexibleretaining tab 1012 to lock the needle channel and secure the needle 1011within the normally open needle channel 1003, now closed around theneedle. The needle and handle may be moved forward and back.

The cable and probe section assembly 1006A, 1006B and 1006C may then beslid in from the proximal (surgeon side) and locked in place by theflexible locking tab 1001. The surgeon may adjust the needle 1011 andhandle 1010 within the needle guide. The surgeon may start with a solidintroducer needle to puncture skin tissue. A sheath may be slid over thesolid introducer needle if its tip is at a medical procedure site viaexternal or internal imaging. If subcutaneous entry of the probe isdesired, the probe may follow the introducer needle into the skin tissuepuncture made by the introducer needle. The introducer needle, dependingon the procedure may be followed by replacing the introducer needle witha hollow biopsy needle or a syringe via the sheath. Any viewed needle,syringe or sheath may be rendered echogenic following the methods andprocedures described in U.S. Provisional Application 62/526,170, filedJun. 28, 2017. A pacer placement procedure for installing and securing apacer through the heart pericardium is described in U.S. provisionalpatent application Ser. No. 62/527,865, filed Jun. 30, 2017,incorporated by reference as to its entire contents. This is one exampleof the use of an embodiment of the present device 1000. In a similarmanner, and without subcutaneous use of the probe housing 105 (only useof the needle of the needle guide), cardiocentesis may be performed byfirst creating a path with a needle 1011 via the needle guide to insidea pericardial space having excess fluid. The needle is covered with asheath under ultrasound vision and a syringe is used and its needleinserted within the pericardial space for removal of excess fluid undervision. Further U.S. provisional patent application Ser. No. 62/527,905filed Jun. 30, 2017, incorporated by reference as to its entire contentsmay be referred to for replacement of a heart valve using the presentdevice 1000. Similarly, a needle is used to place a sheath and anexpanding umbrella and tools for defective heart valve removal orapplied through the sheath under vision and a replacement heart valveinserted replacing the defective heart valve. Other procedures have andwill be discussed herein using an embodiment of device 1000 usingdifferent components of different dimensions and different medicalprocedure capabilities.

In some embodiments, device 1000 (with or without an optional handle)can be steerable and externally controlled by the operator. In someembodiments, one or more Micro-Electro-Mechanical Systems (MEMS) devicescan be incorporated into the use of the device 1000 to allow an operatorto control aspects of the device. MEMS systems can include, for example,mechanical elements (beams, cantilevers, diaphragms, valves, plates, andswitches), sensors, actuators, and electronics. Referring to FIG. 7A ofU.S. patent application Ser. No. 13/847,902, (now U.S. Pat. No.9,149,257), a MEMS position manipulator 701 can be mounted on device 100at a distal portion of device 100 to control a position of transducer210 to, for example, standard position 702, Position A 702 a or PositionB 702 b. In other embodiments, one or more MEMS devices can be providedto function as tiny sensors and actuators. For example, MEMS can beincorporated in the device for measuring and monitoring pressure in thestomach or other organs in which the catheter is inserted, and formeasuring and monitoring blood pressure when performing cardiaccatheterization. According to the present invention, the tool may beprovided with an echogenic surface to improve visibility (see U.S.provisional patent application Ser. No. 62/526,170 filed Jun. 28, 2017for use of echogenicity) and a contrast agent used if appropriate forthe procedure to improve ultrasound visibility of blood vessels.

In another embodiment, for example, as shown in FIG. 7B of U.S. patentapplication Ser. No. 13/847,902, (now U.S. Pat. No. 9,149,257) a MEMSmanipulator lead fixation device 703 can be provided to permit anoperator to remotely access a portion of a device within a patient'sbody. For example, MEMS manipulator 703 can be used to screw in a leadfor a pacemaker implanted in a patient or directly mount a pacemaker tothe pericardium without the use of electrical stimulation leads whichare typically planted in the pericardium according to known procedures.Alternatively, MEMS manipulator 703 can be used to operate a biopsyneedle, syringe, sheath or other tool or to manipulate asuture-application device within a patient. It should be noted thatthese uses are exemplary only and that a device 1000 capable of using aMEMS manipulator as described herein can be used to access or manipulateany device in a body or for any other suitable purpose.

In accordance with aspects described herein, a device 1000 may have abiopsy instrument such as, for example, the biopsy device depicted inFIGS. 8A-8D of U.S. patent application Ser. No. 13/847,902, (now U.S.Pat. No. 9,149,257). In such an embodiment, device 1000 can be adaptedfor use in biopsy procedures including but not limited to myocardialbiopsy, brain biopsy (nasal cavity or ear canal entry to the brain ispossible without probe entry), muscle biopsy, lung biopsy, liver biopsy,kidney biopsy, uterine and ovarian biopsy, esophageal biopsy, stomachbiopsy, intestinal biopsy, tumor biopsy (anywhere), targeted biopsy ofpotentially abnormal zones in any of the above items (e.g., ultrasoundor OCT guided biopsy of an abnormal area in the liver or kidney with thepresent catheter will allow access to the abnormal area, identificationof abnormal zones by deploying the ultrasound and biopsy instrument tothe specific area of interest). As such, device 1000 can, in some cases,be used in the form of a catheter or probe for delivery of a sheath-likedevice that is insertable through small incisions in the body. A biopsytool could be inserted through the needle channel of the device 1000 ascould a syringe needle. As used herein, device 1000 generally refers toany embodiment of an image catheter device or probe of the presentinvention, for example, with or without a handle, with a tapered or flatend, with a tab or a sleeve lock to close the needle channel around atool, the device 1000 having, for example, an imaging channel 1003 and aneedle/instrument channel mounted with the needle guide on top of theultrasound probe or the probe mounted side by side or with theneedle/instrument needle guide assembly being fixable to the device 1000or removable and replaceably attached to the probe housing and withvarying size or diameter of barrel or probe housing depending on theapplication.

In another embodiment, such as is shown in FIGS. 9A and 9B of U.S.patent application Ser. No. 13/847,902, (now U.S. Pat. No. 9,149,257),device 1000 can include a retrieval instrument in combination with abioptome or another custom instrument. As is known in the art, abioptome can comprise a specialized biopsy catheter/probe for use incardiac applications, particularly a catheter/probe with a special enddesigned for obtaining endomyocardial biopsy samples. In use, a bioptomecan be threaded through the needle lumen of the device 1000 to the rightventricle, where it can snip small tissue samples from the septal wallfor pathologic examination. In other uses, a bioptome tip device can beused to monitor heart transplantation patients for early signs of tissuerejection. In use, as seen in FIGS. 9A and 9B of U.S. patent applicationSer. No. 13/847,902, (now U.S. Pat. No. 9,149,257), a retrievalinstrument having a bioptome 903 can be in closed position 901 at adistal end and closed position 904 at a proximal end to assist ininserting the instrument into the area of interest, and then can beplaced into an open position 902 at the distal (patient) end so that thedesired tissue can be retrieved for examination or testing. A tissuesample collected by either a retrieval instrument, a biopsy tool, or abioptome may be removed for analysis either by threading the instrumentout of the body through the needle or sheath lumen, or by removing theentire device from the patient's body along with the tissue sample.

Device 1000 in accordance with one or more aspects described herein canhave many different embodiments for many different uses within the scopeand spirit of the present disclosure. Device 1000 can be in the form ofa catheter and a placed needle can carry a small diameter, minimallyinvasive sheath to a medical procedure site that provides entry intovarious body spaces, thus allowing therapy delivery, intervention,placement of devices and diagnostics. Device 1000 can also be in theform of interventional devices for use in procedures within thesespaces. Such catheters, probes, sheaths, and devices are known, and,thus, the general features of device 1000 for these embodiments can bein accordance with conventional devices.

In addition, when provided with one or more integrated transducers (suchas linear phased arrays) and other components required to provideultrasound imaging as described herein, device 1000 can be used in awide variety of procedures which can be made substantially safer andeasier through the combination of ultrasound imaging aspects withtherapeutic aspects of the ultrasound probe of device 1000.

In some embodiments, device 1000 can be used to provide access tovascular structures including arteries, veins, lymphatics, and to otherhollow structures or body orifices such as the gastrointestinal tract,genitourinary tract, and the respiratory system. As such, the device1000 can be used with, for example, a vascular sheath (not shown, butshown in priority applications and patents). Such sheaths are wellknown, and, thus, the general features of device 1000 for theseembodiments can be in accordance with conventional devices.

In other embodiments, device 1000 can be used in procedures in variousbody spaces such as the pleural peritoneal space, pericardial space,perisphinal space, pelvis, and cerebrospinal space. For example, thedevice can be adapted for use in paracentesis, biopsy of anyintraabdominal or intrapelvic organ, prostate biopsy, biopsy of tumorsor otherwise suspected abnormal structures within the pelvis andabdomen, diagnosis of endometriosis, treatment by chemicals, cells,bio-agents, physical energy (e.g., cryo, radiofrequency, heat, laser) ofany pathology within the pelvis and abdomen, visualization andapplication of therapy within the genitourinary tract, and drainage ofabnormal or normal collection of fluid in actual or potential space inthe abdomen, pelvis or genitourinary tract. In other embodiments, device1000 can be in the form of a catheter/probe which can be used with asyringe to drain fluid from a patient's gall bladder or any other hollowor solid organ in the abdomen.

Other procedures that can be performed using device 1000 includeprocedures relating to diagnosis and treatment of infertility, includingfollowing a woman's ovum to determine an appropriate time for harvest,harvesting the ovum, and assisting in or performing the delivery of thefertilized egg to the uterus (with or without use of a contrast agent orechogenicity).

In some embodiments, device 1000 can be designed for use in cardiac orvascular procedures and for accessing various targets. For example,device 1000 can be designed to provide access to various structures suchas the coronary sinus and other cardiac venous structures. Exemplaryprocedures that can be performed using device 1000 can include:epicardial biopsy; electronic mapping (endocardial or epicardial);electromechanical mapping (endocardial or epicardial); endocardial orepicardial ablation using any form of energy; cannulation or delivery ofcatheters, heart rhythm pacing leads or pacemaker devices, and otherinterventional devices (medicinal pumps for calming tremors inParkinson's disease patients; and mapping and access to the fossa ovalisand patent foramen ovale to enable crossing the atrial septum andallowing transvenous access to the left side of the heart;pericardiocentesis; left ventricular lead placement; delivery of therapy(e.g., drugs, stem cells, laser therapy, or ultrasound energy);epicardial coronary artery bypass; valve repair and placement, deliveryof cardiac shape modifying devices (e.g., ACORN® or MYOSPLINT® devices);myocardial scar reconstruction; ventricular reconstruction; ventricularassist device placement; and the treatment by chemicals, cells,bio-agents, physical energy (e.g., cryo, radiofrequency, heat, laser) ofany pathology within the pericardial space or myocardium orintracardiac. As such, device 1000 can, in some cases, be used with asheath-like device introduced via an image-guided needle that isinsertable through, for example, a needle puncture in the patient'supper thigh and through a blood vessel all the way up to the heart. Insuch embodiments, guidewire can be used with the device 1000 to guidethe device 1000 to the target area for guidewire introduction throughthe vein. In other embodiments, the device 1000 can be inserted throughthe pericardial space through the use of an introducer needle or sheathintegrated therein.

In other embodiments, device 1000 can be in the form of a device that isused in performing a cardiac procedure such as a biopsy instrument or aninstrument for heart valve repair or replacement. In this case, device1000 can be provided with one or more transducer imaging systems or usedwith auxiliary imaging systems such as OCT, along with the othercomponents required to provide ultrasound imaging using the transducersas discussed herein and tools to implement the repair or replacement,for example, of a heart valve with or without contrast or usingechogenicity (for the tool or use of the contrast agent in proximateheart tissue).

In other embodiments, device 1000 can be in the form of devices for usein performing procedures on the musculo-skeletal system and foraccessing the musculoskeletal system. For example, device 1000 can beused for treatment by chemicals, cells, bio-agents, or physical energy(cryo, radiofrequency, heat, laser) of any pathology within the jointcavity, joint components, or muscle and bone; visualization andapplication of therapy involving muscle, bone, and joint components,including a joint cavity; and drainage of abnormal or normal collectionof fluid in actual or potential space in the muscle, bone, or jointcomponents. In these embodiments, device 1000 can be in the form of acatheter or sheath that provides access to the musculo-skeletal system,thus allowing therapy delivery, intervention, placement of devices anddiagnostics. Device 1000 can also be in the form of interventionaldevices for use in procedures on the musculo-skeletal system. Suchcatheters, sheaths, and devices are well known, and, thus, the generalfeatures of device 1000 for these embodiments can be in accordance withconventional devices. Device 1000 would further include one or moretransducer assemblies such as linear phased arrays, along with the othercomponents required to provide ultrasound imaging using the transducerassemblies as discussed herein.

In some embodiments, device 1000 can be in the form of devices for usein procedures on the brain and nervous system and for accessing thebrain and nervous system. For example, such devices can be used for thetreatment by chemicals, cells, bioagents, or physical energy (cryo,radiofrequency, heat, laser) of any pathology within the cranium andspinal and pen-spinal space including the vasculature contained within;visualization and application of therapy within the cranium, spinal, andpen-spinal space and all contained vasculature; drainage of abnormal ornormal collection of fluid in actual or potential space in the cranium,spinal, and pen-spinal space and all contained vasculature; and fortranscatheter delivery of interventional devices such as aneurysm clips,hematologic treatments, and any other drug or non drug therapy, eitherdirectly or via the vasculature or via any other hollow structure withinthe cranium, spinal, and peri-spinal space and all containedvasculature. In these embodiments, device 1000 can be in the form of acatheter or sheath that provides access to the brain and system, thusallowing therapy delivery, intervention, placement of devices anddiagnostics. Ultrasound visualization need not be subcutaneous butexternal or via a body orifice such as the nasal passages and ear canal.

Device 1000 can further be adapted for use in procedures on the nasalpassages, sinuses, ear canals and pharynx and other orifices and foraccessing these orifices to reach organs such as the brain and thethroat and such as via the esophagus for accessing the heart. In theseembodiments, device 1000 can be in the form of a catheter and use asheath that provides access to a desired site of the nasal passages,sinuses, pharynx and heart, thus allowing therapy delivery,intervention, placement/replacement of devices and defective heartvalves and diagnostics. Device 1000 can also be in the form ofinterventional devices for use in procedures on the nasal passages,sinuses, and pharynx (e.g., devices for therapy delivery, intervention,placement of devices and diagnostics). Such catheters, sheaths, anddevices are well known, and, thus, the general features of device 1000for these embodiments can be in accordance with conventional devices.Device 1000 would further include one or more transducers, along withthe other components required to provide ultrasound imaging using thetransducers as discussed herein. Device 1000 can further be in the formof devices used to treat and address chronic problems and, as such, canbe delivered and lodged in body cavities, organs, or other anatomiclocations for long term monitoring or anatomy or function or dynamicsincluding hemodynamics. In these examples, the device 1000 can be in theform of a catheter or probe and introduce a sheath or other conventionalchronic treatment or monitoring device that can be lodged at a desiredsite. Device 1000 may further include one or more transducer probes,along with the other components required to provide ultrasound imagingusing the transducer assemblies as discussed herein. Device 1000 canalso be used for implanting a monitoring or drug delivery device at aspecific site in the body using its imaging capabilities to assist theuser in finding a precise target site. In some embodiments, the presentdevice 1000 can further be integrated with other non-ultrasound imagingmodalities including infrared, laser, CT scan, X-ray, optical coherencetomography, fiber optic instruments including, but not limited toendoscopic mapping. For example, the imaging lumen or probe can furtherbe provided with a fiber optic lumen through which an optical fiber isinsertable in place or proximate to the linear phased array.

The devices 1000 can be used to perform any variety of medicalprocedures including those set forth herein. The general features ofthese procedures are in accordance with conventional procedures andfurther make use of the integrated imaging system to providevisualization while accessing and performing procedures at the targetsite. Access to other organs, structures, and spaces can be performed insimilar fashion with appropriate procedural modifications specific forthe particular organs, structures or spaces.

All documents mentioned herein are incorporated by reference herein asto any description which may be deemed essential to an understanding ofillustrated and discussed aspects and embodiments of devices and methodsherein.

Although the devices and methods discussed above and primarilyillustrated and described herein provide instruments that also can beadapted for performing minimally invasive diagnostic or therapeuticprocedures on humans, it will be appreciated by those skilled in the artthat such instruments and methods also are adaptable for use in othersurgical procedures as well as in performing various veterinarysurgeries. Further, while several preferred embodiments have beendescribed using specific terms, such description is for illustrativepurposes only, and it is to be understood that changes and variationsmay be made without departing from the spirit or scope of the followingclaims.

What is claimed is:
 1. A sheath body comprising: a closed-end lumenconfigured to receive a forward looking imaging device, wherein a distalportion of the closed-ended lumen is off-set from a proximal portion ofthe closed-ended lumen; and an open-ended lumen that comprises a firstmovable guide and a second movable guide; is configured to transitionbetween an open configuration in which a surface of the first movableguide and a surface of the second movable guide do not contact eachother and a closed configuration in which the surface of the firstmovable guide and the surface of the second movable guide contact eachother; and is configured to receive a medical tool, wherein theopen-ended lumen does not extend to a proximal end of the closed-endedlumen and the open-ended lumen is oriented with respect to theclosed-end lumen such that when the medical tool is loaded into theopen-ended lumen, a portion of the medical tool that protrudes from theopen-ended lumen is within a forward imaging field of view of theforward looking imaging device.
 2. The sheath body of claim 1, whereinthe open-ended lumen is configured to transition between the openconfiguration and the closed configuration such that the medical tool isinsertable and removable from the sheath body when the open-ended lumenis in the open configuration.
 3. The sheath body of claim 2, wherein theopen-ended lumen is configured to open and close along an entire toplength of the open-ended lumen.
 4. The sheath body of claim 1, whereinthe open-ended lumen comprises one or more tabs to facilitate ejectionof the medical tool from the open-ended lumen when the open-ended lumenis in the open configuration.
 5. The sheath body of claim 1, wherein theopen-ended lumen comprises an actuation mechanism coupled to theopen-ended lumen to control opening and closing of the open-ended lumen.6. The sheath body of claim 1, wherein the open-ended lumen comprises alocking mechanism that locks the open-ended lumen in the closedconfiguration.
 7. The sheath body of claim 1, wherein the open-endedlumen is further oriented with respect to the closed-end lumen such thata forward-imaging orientation of the medical tool is produced by theforward looking imaging device.
 8. The sheath body of claim 1, whereinthe open-ended lumen does not extend beyond the proximal portion of theclosed-ended lumen.
 9. The sheath body of claim 1, wherein a distal endof the closed-end lumen is blunt.
 10. The sheath body of claim 1,wherein the open-ended lumen is sized to receive a medical tool that isa needle or a syringe.
 11. A method of performing an image guidedmedical procedure on a subject, the method comprising: providing asheath body comprising a closed-end lumen configured to receive aforward looking imaging device, wherein a distal portion of theclosed-ended lumen is off-set from a proximal portion of theclosed-ended lumen; and an open-ended lumen that comprises a firstmovable guide and a second movable guide; is configured to transitionbetween an open configuration in which a surface of the first movableguide and a surface of the second movable guide do not contact eachother and a closed configuration in which the surface of the firstmovable guide and the surface of the second movable guide contact eachother; and is configured to receive a medical tool, wherein theopen-ended lumen does not extend to a proximal end of the closed-endedlumen and the open-ended lumen is oriented with respect to theclosed-end lumen such that when the medical tool is loaded into theopen-ended lumen, a portion of the medical tool that protrudes from theopen-ended lumen is within a forward imaging field of view of theforward looking imaging device; loading a forward looking imaging deviceinto the closed-end lumen, wherein the forward looking imaging devicecomprises a distal portion that is off-set from a proximal portion suchthat the off-set portion of the forward looking imaging device entersthe off-set portion of the sheath body; loading a medical tool into theopen-ended lumen; and performing at least a portion of a medicalprocedure on a subject using the medical tool loaded in the open-endedlumen while viewing the medical tool through the forward imaging fieldof view of the forward looking imaging device.
 12. The method of claim11, further comprising opening the open-ended lumen to remove themedical tool from the sheath body while performing the medicalprocedure.
 13. The method of claim 12, further comprising: loading asecond medical tool into the open-ended lumen while the open ended lumenis in the open configuration; closing the open-ended lumen; andcontinuing to perform the medical procedure on the subject using thesecond medical tool loaded in the open-ended lumen while viewing thesecond medical tool through the forward imaging field of view of theforward looking imaging device.
 14. The method of claim 11, wherein thesheath body is positioned on a surface of the subject while the medicaltool is positioned within the subject.
 15. The method of claim 11,wherein a portion of the sheath body is positioned in the subject. 16.The method of claim 11, wherein the open-ended lumen is configured toopen and close along an entire length of the open-ended lumen.
 17. Themethod of claim 11, wherein the open-ended lumen is configured to openand close along an entire top length of the open-ended lumen.
 18. Themethod of claim 11, wherein the open-ended lumen comprises one or moretabs to facilitate ejection of the medical tool from the open-endedlumen when the open-ended lumen is in the open configuration.
 19. Themethod of claim 11, wherein the open-ended lumen comprises an actuationmechanism coupled to the open-ended lumen to control opening and closingof the open-ended lumen.
 20. The method of claim 11, wherein theopen-ended lumen comprises a locking mechanism that locks the open-endedlumen in the closed configuration.